Surgical Devices, Dressings, and Wound Care Supplies
Number: 0526
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses surgical dressings (wound care supplies).
-
Medically Necessary
Aetna considers the following surgical wound care supplies medically necessary:
-
Wound Covers
Wound covers are flat dressing pads. A wound cover with adhesive border is one that has an integrated cover and distinct adhesive border designed to adhere tightly to the skin. When a wound cover with an adhesive border is being used, no other dressing would be used on top of it and additional tape is usually not considered medically necessary. Reasons for use of additional tape should be documented. An adhesive border is usually more binding than that obtained with separate taping and is therefore considered medically necessary for use with wounds requiring less frequent dressing changes.
-
Quantity of Surgical Dressings
No more than a 1-month's supply of dressings is considered medically necessary at one time, unless there is documentation to support the medical necessity of greater quantities in the home setting in an individual case. An even smaller quantity may be appropriate in the situations described above. The medically necessary quantity and type of dressings dispensed at any one time must take into account the current status of the wound(s), the likelihood of change, and the recent use of dressings. Dressing needs may change frequently (e.g., weekly) in the early phases of wound treatment and/or with heavily draining wounds. Suppliers are also expected to have a mechanism for determining the quantity of dressings that the person is actually using and to adjust their provision of dressings accordingly.
-
Surgical Dressing Kits
When surgical dressing kits are used for the provision of surgical dressings, all components of the kit will be considered not medically necessary. A surgical dressing kit is defined as non-individualized, standardized packaging containing repetitive quantities of dressings not related to the individual medical needs of a member, or whose contents have not each been prescribed for the care of the specific wounds of that member, or that contain materials in addition to surgical dressings. Surgical dressings must be tailored to the specific needs of an individual member. This can not be accomplished when dressings are provided as kits or trays containing fixed quantities and/or multiple types of dressings.
-
Wound Fillers
Wound fillers are dressing materials that are placed into open wounds to eliminate dead space, absorb exudate, or maintain a moist wound surface. Wound fillers come in hydrated forms (e.g., pastes, gels), dry forms (e.g., powder, granules, beads), or other forms (e.g., rope, spiral, pillows, etc).
-
Dressings
Note: Products containing multiple materials are categorized according to the clinically predominant component (e.g., alginate, foam, gauze, hydrocolloid, hydrogel). Other multi-component wound dressings not containing these specified components may be classified as composite or specialty absorptive dressings if the definition of these categories has been met. Gauze or gauze-like products are typically manufactured as a single piece of material folded into a several ply gauze pad. Use of more than one type of wound filler or more than one type of wound cover in a single wound is rarely considered medically necessary. It may not be considered medically necessary to use some combinations of a hydrating dressing on the same wound at the same time as an absorptive dressing (e.g., hydrogel and alginate).
Because composite dressings, foam and hydrocolloid wound covers, and transparent film, when used as secondary dressings, are meant to be changed at frequencies less than daily, appropriate clinical judgment should be used to avoid their use with primary dressings which would require more frequent dressing changes. For these dressings, changes greater than once every other day are not considered medically necessary. While a highly exudative wound might require such a combination initially, with continued proper management the wound should progress to a point where the appropriate selection of these products should result in the less frequent dressing changes which they are designed to allow. An example of a combination that would be considered not medically necessary is the use of a specialty absorptive dressing on top of non-impregnated gauze being used as a primary dressing.
Dressing size should be based on and appropriate to the size of the wound. For wound covers, the medically necessary pad size should usually be about 2 inches greater than the dimensions of the wound. For example, a 5 cm X 5 cm (2 in. X 2 in.) wound would require a 4 in. X 4 in. pad size.
The following are some specific medical necessity guidelines for individual products when the products themselves are considered medically necessary in the individual member. The medical necessity for more frequent change of dressing should be documented in the member's medical record.
-
Alginate or other Fiber Gelling Dressing
Examples of alginate gelling dressings include Algesite (Smith & Nephew), Kaltostat (ConvaTec), Sorbsan (Coloplast), Maxorb (Medline Industries), and Melgisorb (Mölnlycke Health Care). Examples of other fiber gelling dressings include Kerracel (3M) Gelling Fiber Dressing, AGILE (OVIK Health), AQUACEL (Lohmann & Rauscher GmbH and Co. KG), Biosorb (Acelity), Durafiber (Smith & Nephew).
Alginate or other fiber gelling dressing covers are considered medically necessary for moderately to highly exudative full thickness wounds (e.g., stage III or IV ulcers); and alginate or other fiber gelling dressing fillers for moderately to highly exudative full thickness wound cavities (e.g., stage III or IV ulcers). They are of no proven benefit on dry wounds or wounds covered with eschar. Up to 1 dressing change per day is considered medically necessary, unless the medical necessity of more frequent changes is documented. One wound cover sheet of the approximate size of the wound or up to 2 units of wound filler (1 unit = 6 inches of alginate or other fiber gelling dressing rope) would be considered medically necessary for each dressing change, unless the medical necessity for more wound cover or filler is documented. It is usually not considered medically necessary to use alginates or other fiber gelling dressings in combination with hydrogels.
-
Composite Dressing
(Including Mepore Pro (waterproof outer layer, absorbent pad, adhesive backing) (Mölnlycke Health Care AB)), Mepore Self-Adhesive Absorbent Dressing (Mölnlycke Health Care AB), Covaderm Plus (Colavon Technologies Ltd), DermaDress (Medline Industries), Leukomed (BSN medical GmBH), DermaView II Island (DermaRite Industries, LLC), ZeniPAD Plus (ZeniMedical))
Common situations where composite dressings are needed include: fistulas or sinuses require absorption of exudate and protection from contamination; wounds with irregular contours or difficult-to-dress areas, such as joints or creases; surgical wounds with significant exudate; and complex traumatic wounds.
Up to 3 composite dressing changes per week are considered medically necessary, 1 wound cover per dressing change, unless it is documented that more frequent changes are medically necessary. Composite dressings are products combining physically distinct components into a single dressing that provides multiple functions. These functions must include, but are not limited to:
- A bacterial barrier,
- An absorptive layer other than an alginate, foam, hydrocolloid, or hydrogel
- Either a semi-adherent or non-adherent property over the wound site, and
- An adhesive border.
-
Contact Layer Dressing
Examples of silicone contact layer dressings include Mepitel and Mepitel One (Mölnlycke Health Care AB), Adaptic Touch (3M), Silflex (Advancis Medical), and Cuticell Contact (BSN medical GmbH, now part of Essity). Examples of traditional contact layer dressing brands include Adaptic (3M), Xeroform (manufactured by several companies, including McKesson, Gentell, and Curad (Medline)), and Vaseline Petrolatum Gauze (Covidien/Medtronic).
Up to 1 contact layer dressing change per week is considered medically necessary, unless it is documented that more frequent changes are medically necessary. Contact layers are thin non-adherent sheets placed directly on an open wound bed to protect the wound tissue from direct contact with other agents or dressings applied to the wound. They are porous to allow wound fluid to pass through for absorption by an overlying dressing. Contact layer dressings are used to line the entire wound; they are not intended to be changed with each dressing change.
-
Foam Dressing
(Including Biatain (Coloplast), Optifoam (Medline Industries), PolyMem (Ferris Mfg. Corp.), Mepilex (Mölnlycke Health Care), Allevyn (Smith & Nephew), and Betafoam (Genewell))
Foam dressings are considered medically necessary when used on full thickness wounds (e.g., stage III or IV ulcers) with moderate to heavy exudate. Usual dressing change for a foam wound cover used as a primary dressing is up to 3 times per week. When a foam wound cover is used as a secondary dressing for wounds with very heavy exudate, dressing changes may be medically necessary up to 3 times per week. Up to 1 dressing change for foam wound fillers per day is considered medically necessary, unless it is documented that more frequent changes are medically necessary.
-
Gauze, Non-Impregnated
For a dressing without a border, up to 3 non-impregnated gauze dressing changes per day are considered medically necessary, unless there is documentation that more frequent changes are medically necessary. For dressing changes with a border, 1 change per day is considered medically necessary, unless more frequent changes are medically necessary. It is usually not considered medically necessary to stack more than 2 gauze pads on top of each other in any one area.
-
Gauze, Impregnated, other than Water or Normal Saline, Hydrogel, or Zinc Paste
Up to 1 dressing change per day is considered medically necessary for gauze dressings impregnated with other than water, normal saline, hydrogel, or zinc paste, unless there is documentation that more frequent changes are medically necessary. Impregnated gauze dressings are woven or non-woven materials in which substances such as iodinated agents, petrolatum, zinc compounds, crystalline sodium chloride, chlorhexadine gluconate (CHG), bismuth tribromophenate (BTP), water, aqueous saline, or other agents have been incorporated into the dressing material by the manufacturer.
Note: However, when the dressing and the substance with which it is impregnated are listed in combination in the Food and Drug Administration (FDA) Orange Book (e.g., an antibiotic impregnated dressing which requires a prescription), then the entire item is considered a drug which would be covered under the pharmacy benefit if self-administered, ordered by a physician and available by prescription.
-
Gauze, Impregnated, Water or Normal Saline
There is no medical necessity for these dressings compared to non-impregnated gauze, which is moistened with bulk saline or sterile water.
Note:Bulk saline or sterile water is not covered.
-
Hydrocolloid Dressing
(Including Comfeel (Coloplast), DuoDERM (ConvaTec), Exuderm (Medline Industries), and Replicare (Smith & Nephew))
Hydrocolloid dressings are considered medically necessary for use on wounds with light to moderate exudate. Up to 3 dressing changes per week are considered medically necessary for hydrocolloid wound covers or hydrocolloid wound fillers, unless it is documented that more frequent changes are medically necessary.
-
Hydrogel Dressing
(Including Intrasite (Smith & Nephew), Solosite (Smith & Nephew), Elasto-Gel (Southwest Technologies), and DuoDERM Gel (ConvaTec))
Hydrogel dressings are considered medically necessary when used on full thickness wounds with minimal or no exudate (e.g., stage III or IV ulcers). Hydrogel dressings are typically of no proven benefit for stage II ulcers. Documentation must substantiate the medical necessity for use of hydrogel dressings for stage II ulcers (e.g., location of ulcer is sacro-coccygeal area). For hydrogel wound covers without adhesive borders or hydrogel wound fillers, up to 1 dressing change per day is considered medically necessary, unless it is documented that more frequent dressing changes are medically necessary. For hydrogel wound covers with adhesive borders, up to 3 dressing changes per week are considered medically necessary, unless it is documented that more frequent changes are medically necessary.
The medically necessary quantity of hydrogel filler used for each wound should not exceed the amount needed to line the surface of the wound. Additional amounts used to fill a cavity are not considered medically necessary. Documentation must substantiate the medical necessity for hydrogel filler billed in excess of 3 units (fluid ounces) per wound in 30 days.
Use of both a hydrogel filler and a hydrogel cover on the same wound at the same time is of no proven benefit.
-
Specialty Absorptive Dressing
(Including ConvaMax (ConvaTec) and Drawtex (Breier Drawtex Healthcare))
Specialty absorptive dressings are considered medically necessary when used for moderately or highly exudative wounds (e.g., stage III or IV ulcers). Up to 1 change of specialty absorptive dressing per day is considered medically necessary for a dressing without an adhesive border, and up to 1 dressing change every other day is considered medically necessary for a dressing with a border, unless it is documented that more frequent changes are medically necessary. Specialty absorptive dressings are unitized multi-layer dressings which provide either a semi-adherent quality or non-adherent layer, and highly absorptive layers of fibers such as absorbent cellulose, cotton, or rayon. These may or may not have an adhesive border.
-
Transparent Film
(Including Opsite (Smith & Nephew))
Transparent film dressings are considered medically necessary when used on open partial thickness wounds with minimal exudate or closed wounds. Up to 3 transparent film dressing changes per week are considered medically necessary, unless it is documented that more frequent dressing changes are medically necessary.
-
Gauze, Elastic
The medically necessary frequency of elastic gauze dressing changes is determined by the frequency of changes of the selected primary dressing. Overlying elastic gauze is of no proven benefit when a dressing is secured with tape or has an adhesive border.
-
Gauze, Non-Elastic
The medically necessary frequency of non-elastic gauze dressing changes is determined by the frequency of change of the selected primary dressing. Overlying non-elastic gauze is of no proven benefit when a dressing is secured with tape or has adhesive border.
-
-
Wound Filler, not elsewhere classified
Up to 1 dressing change per day is considered medically necessary, unless it is documented that more frequent changes are needed.
-
Wound Pouch
A wound pouch is a waterproof collection device with a drainable port that adheres to the skin around a wound. Up to 3 dressing changes per week are considered medically necessary, unless the medical necessity of more frequent changes is documented.
-
Tape
Tape is considered medically necessary to hold on a wound cover, elastic roll gauze or non-elastic roll gauze. Additional tape is usually not considered medically necessary when a wound cover with an adhesive border is used. The medical necessity for tape in these situations should be documented. The medically necessary frequency of tape change is determined by the frequency of change of the wound cover. Quantities of tape submitted should reasonably reflect the size of the wound cover being secured. The following amounts of tape are considered medically necessary, unless the medical necessity of additional tape is documented: for wound covers measuring 16 square inches or less, up to 2 units per dressing change is considered medically necessary; for wound covers measuring 16 to 48 square inches, up to 3 units per dressing change is considered medically necessary; for wound covers measuring greater than 48 square inches, up to 4 units per dressing change is considered medically necessary.
-
Elastic Bandage
Elastic bandages are considered medically necessary when used as a secondary dressing to hold wound cover dressings in place. When an elastic bandage is used over a wound cover with adhesive border or over a wound cover which is held in place by tape, elastic roll gauze or non-elastic roll gauze, or transparent film, the elastic bandage is of no proven benefit. Elastic bandages have also not been proven useful for strains, sprains, edema, or situations other than as a secondary surgical dressing.
Most elastic bandages are reusable. No more than 1 replacement per week is considered medically necessary, unless the medical necessity of more frequent replacements is documented.
-
Tissue Adhesives, Tissue Sealants, Hemostatic Agents
Note: The use of tissue adhesives, tissue sealants or hemostatic agents as an alternative to sutures in wound closure is considered integral to the surgical procedure and not separately reimbursed.
-
Light Compression Bandage, Moderate/High Compression Bandage, Self-Adherent Bandage, Conforming Bandage, Padding Bandage
Most compression bandages are reusable. Usual medically necessary frequency of replacement would be no more than one per week unless they are part of a multi-layer compression bandage system.
The medical necessity of conforming bandage dressing change is determined by the frequency of change of the selected underlying dressing.
-
Gradient Compression Wrap
A gradient compression stocking or a non-elastic gradient compression wrap is considered medically necessary when it is used in the treatment of an open venous stasis ulcer. The medically necessary frequency of a non-elastic gradient compression wrap is limited to one per 6 months per leg. Quantities exceeding this amount will be denied as not medically necessary.
-
Negative Pressure Dressings
Aetna considers negative pressure dressings not medically necessary for open fractures because they are no better than standard dressings for open fractures. (See CPB 0334 - Negative Pressure Wound Therapy).
-
Dressings over a Percutaneous Catheter or Tube
Note:Under all plans, medically necessary dressings over a percutaneous catheter or tube (e.g., intravascular, epidural, nephrotomy, etc.) are covered as long as the catheter or tube remains in place and after removal until the wound heals.
-
-
Experimental, Investigational, or Unproven
-
Examples of situations in which dressings are of no proven benefit because of insufficient evidence in the peer-reviewed literature include the following:
-
A first degree burn;
-
A stage I pressure ulcer;
-
A venipuncture or arterial puncture site (e.g., blood sample) other than the site of an indwelling catheter or needle;
-
Drainage from a cutaneous fistula which has not been caused by or treated by a surgical procedure;
- Wounds caused by trauma that do not require surgical closure or debridement (e.g., skin tear or abrasion).
-
-
The following are considered experimental, investigational, or unproven because the effectiveness of these approaches has not been established:
- Amino acid dressings for the management of chronic wounds
- Automatic Continuous Effusion Shunt (ACES) System (Pleural Dynamics)
- CLR Irrigator
- Colovac endoluminal bypass sheath as an alternative to temporary diverting ostomy for individuals undergoing colorectal resection
- Continuous combined positive and negative pressure dressing for preventing recurrence of auricular seroma
- Dialkylcarbomoyl chloride (DACC)-coated dressing for surgical site infection
- Ibuprofen foam dressings for painful venous leg ulcers
- Intrauterine biodegradable hydrogels (Juveena, Rejoni, Inc.)
- OxyBand wound dressing
- Percutaneous tissue displacement procedures.
-
-
Policy Limitations and Exclusions
Aetna’s standard traditional plans (Managed Choice POS, PPO, and indemnity) cover medically necessary surgical dressings only when prescribed by a physician and supplied by a home care agency in conjunction with covered home health care services or when dispensed and used by a participating health care provider in conjunction with treatment of the member. Under Aetna traditional plans, supplies are not covered when they do not require a prescription and can be purchased by the member over-the counter or when they are given to the member as take-home supplies. Please check benefit plan descriptions.
Aetna’s standard HMO plans cover surgical dressings when they are medically necessary for wound debridement or for the treatment of a wound caused by, or treated by, a surgical procedure. Please check benefit plan descriptions.
Covered surgical dressings include both medically necessary primary dressings (i.e., therapeutic or protective coverings applied directly to wounds or lesions either on the skin or caused by an opening to the skin) and medically necessary secondary dressings (i.e., materials that serve a therapeutic or protective function and that are needed to secure a primary dressing). Items such as adhesive tape, roll gauze, or elastic bandages are examples of secondary dressings. Elastic stockings, support hose, foot coverings, leotards, knee supports, surgical leggings, gauntlets, and pressure garments for the arms and hands are examples of items that are not ordinarily covered as surgical dressings.
-
Note on Debridement
Debridement of a wound may be any type of debridement, including surgical (e.g., sharp instrument or laser), mechanical (e.g., irrigation or wet-to-dry dressings), chemical (e.g., topical application of enzymes), or autolytic (e.g., application of occlusive dressings to an open wound). Medically necessary dressings used for mechanical debridement, to cover chemical debriding agents, or to cover wounds to allow for autolytic debridement are covered under both HMO and traditional plans under the surgical dressings benefit, although the chemical debriding agents themselves, if self-administered, are covered under the pharmacy benefit.
-
Note on Wound Care Items not Covered under the Surgical Dressings Benefit
The following are examples of wound care items which would not be covered under the surgical dressings benefit:
-
Enzymatic debriding agents,
-
Gauze or other dressings used to cleanse or debride a wound but not left on the wound,
-
Skin sealants or barriers,
-
Solutions used to moisten gauze (e.g., saline),
-
Topical antibiotics,
-
Topical antiseptics,
- Wound cleansers or irrigating solutions.
If medically necessary and available by prescription, some of these items may be covered under the pharmacy benefit if ordered by a physician.
-
-
Notes on Relationship with Other Policies
Under both HMO and traditional plans, charges for disposable supplies and accessories may also be covered when required to operate durable medical equipment or prosthetic devices (e.g., tracheostomy supplies, urologic supplies, ostomy supplies, dialysis supplies, etc.).
-
Background
This policy is based in part upon Medicare DMERC criteria.
In a prospective, observational study, Cassino and Ricci (2010) examined if the topical application of an amino acid dressing, Vulnamin, aids the management of chronic wounds. A total of 160 patients with non-infected cutaneous chronic wounds were recruited. Before treatment, wound size was assessed using digital planimetry. Treatment lasted for a maximum of 6 weeks. Wound area measurements were repeated 2 and 6 weeks after starting treatment. There was a significant reduction in the mean wound area after 2 weeks (7.4 +/- 8.7 cm2) and 6 weeks (4.6 +/- 6.3 cm2) of treatment, when compared with baseline (11.2 +/- 12.1 cm2, p < 0.01). At the final follow-up, 23 % of patients (n = 36) healed and 34 % (n = 54) achieved a greater than 60 % reduction in wound size. A total of 76 % (n = 120) of subjects achieved positive outcomes (defined as a greater than 40 % reduction in the ulcer size). The authors concluded that although further investigations on the potential effects of this product on chronic wound healing are needed, these findings suggest amino acid dressings may promote healing in venous, pressure and diabetic ulcers.
In a Cochrane review, Briggs and Nelson (2010) evaluated the effectiveness of dressings, local anesthetics or topical analgesia for pain relief in venous leg ulceration. For this update, the search strings were revised and the following databases were searched: The Cochrane Wounds Group Specialised Register (searched 16/12/09) The Cochrane Central Register of Controlled Trials (CENTRAL) - The Cochrane Library Issue 4 2009; Ovid MEDLINE - 1950 to November Week 3 2009; Ovid EMBASE - 1980 to 2009 Week 50; EBSCO CINAHL - 1982 to December 16 2009. No date or language restrictions were applied. Randomized controlled trials (RCTs) that evaluated local interventions used to relieve venous leg ulcer pain were considered. Pain was defined as either persistent pain or pain at dressing changes or debridement. Ulcer healing and reported adverse events were also considered as further outcomes. Eligibility for inclusion was confirmed by 2 review authors who independently assessed the potential trials. Two trials evaluating interventions for persistent venous leg ulcer pain were identified for this review update. Both studies evaluated ibuprofen slow release foam dressings; one comparing it with local best practice and the other with an identical foam comparator. The primary end point for both studies was "pain relief achieved". When compared with a foam dressing alone, there was no evidence of a statistically significant effect of the ibuprofen foam dressing in terms of achieving some pain relief the first evening after treatment: 74 % in the ibuprofen group (46/62) had pain relief compared with 58 % (35/60) in the foam group (no significant difference: relative risk [RR] 1.27, 95 % confidence interval (CI): 0.98 to 1.65). In the second study 100 % (32/32) of people with venous ulcers achieved some pain relief with the ibuprofen dressing on the first evening of treatment compared with 93 % (26/28) in the local best practice group (no significant difference: RR 1.08, 95 % CI: 0.96 to 1.21). Pooling these studies in a meta-analysis (using a random effects model as significant heterogeneity present (p = 0.1), I(2) = 64 %) there is no evidence that ibuprofen dressings increase the pain relief experienced by the first evening of use (RR 1.15, 95 % CI: 0.91 to 1.44). These investigators were unable to extract sufficient data to combine other pain outcomes from these trials. There was no difference in healing rates but slightly more adverse events with ibuprofen dressings than with a similar foam dressing without ibuprofen. Six trials evaluated interventions for the pain associated with debridement and were considered sufficiently similar to pool. There was a statistically significant reduction in debridement pain scores with 5 % eutectic mixture of local anesthetics (EMLA): lidocaine-prilocaine cream; the difference in means (measured on a 100-mm scale) was 20.6 mm (95 % CI: 12.19 to 29.11). Of these 6 trials, only 1 small trial measured healing as an outcome and found no difference in the numbers of ulcers healed at the end of the study. The authors concluded that there is no evidence that ibuprofen dressings offer pain relief, as measured at the first evening of use, to people with painful venous leg ulcers compared with foam dressings or best practice. Eutectic mixture of local anesthetics appears to provide effective pain relief for venous leg ulcer debridement but the effect (if any) of EMLA on ulcer healing remains unknown.
In a Cochrane review, Coulthard et al (2010) examined the relative effects of various tissue adhesives and conventional skin closure techniques on the healing of surgical wounds. These investigators searched the Cochrane Wounds Group Specialised Register (searched 17/11/09); the Cochrane Central Register of Controlled Trials (CENTRAL) - the Cochrane Library Issue 4 2009; Ovid MEDLINE - 1950 to November Week 1 2009; Ovid EMBASE - 1980 to 2009 Week 46; EBSCO CINAHL - 1982 to 17 November 2009. No date or language restrictions were applied. Only RCTs were eligible for inclusion. Screening of eligible studies and data extraction were conducted independently and in triplicate while assessment of the methodological quality of the trials was conducted independently and in duplicate. Results were expressed as random effects models using mean difference for continuous outcomes and relative risks with 95 % CI for dichotomous outcomes. Heterogeneity was investigated including both clinical and methodological factors. This update identified an additional 6 trials resulting in a total of 14 RCTs (1,152 patients) which met the inclusion criteria. Sutures were significantly better than tissue adhesives for minimising dehiscence (10 trials). Sutures were also found to be significantly faster to use. For all other analyses of infection, patient and operator satisfaction and cost there was no significant difference between sutures and tissue adhesives. No differences were found between tissue adhesives and tapes (2 trials) for minimising dehiscence, infection, patients assessment of cosmetic appearance, patient satisfaction or surgeon satisfaction. However a statistically significant difference in favor of using tape was found for surgeons' assessment of cosmetic appearance (mean difference 13, 95 % CI: 5 to 21). Tapes were also demonstrated to be significantly faster to use than tissue adhesives as were staples (1 trial). No other outcome measures were analysed in this group. One trial compared tissue adhesives with a variety of methods of wound closure and found both patients and clinicians were significantly more satisfied with the alternative closure methods than the adhesives. In this same trial, tissue adhesives were significantly less time consuming to use. For the remaining outcomes of dehiscence and infection no difference was observed between groups. This trial also compared high viscosity with low viscosity adhesives and found that high viscosity adhesives were less time consuming to use than low viscosity tissue adhesives. For all other outcomes of dehiscence, infection, patient satisfaction and operator satisfaction there was no statistically significant difference between high and low viscosity adhesives. The authors concluded that sutures were significantly better than tissue adhesives for minimizing dehiscence and were found to be significantly faster to use. Although surgeons may consider the use of tissue adhesives as an alternative to other methods of surgical site closure in the operating theater, they must be aware that adhesives may take more time to apply and that if higher tension is needed upon an incision, sutures may minimize dehiscence. The authors stated that there is a need for more well-designed RCTs comparing tissue adhesives and alternative methods of closure. These trials should include people whose health may interfere with wound healing and surgical sites of high tension.
Lund-Nielsen et al (2011) stated that between 5 % and 10 % of cancer patients develop malignant wounds. In-vitro and some clinical studies suggest that silver- or honey-coated dressings may have an anti-bacterial effect in non-malignant wounds, but their possible anti-bacterial effect in malignant wounds remains unknown. A prospective, randomized, single-blind, controlled clinical study was conducted to evaluate the bacteriology of malignant wounds and compare the effect of a honey-coated (Group A) to a silver-coated (Group B) dressing on the qualitative bacteriology of malignant wounds. All wound interventions were performed by the same healthcare professional. Swab cultures were obtained at baseline and following a 4-week intervention and were evaluated without information about the patient treatment group. Of the 75 patients with advanced cancer and malignant wounds identified, 67 (34 in group A, 33 in group B; median age of 64 years, range of 47 to 92) consented to participate and completed the 4-week study. The majority were women (88 %) with breast cancer (79 %). No statistically significant differences were found between the type and number of different wound pathogens in the wounds during the course of the study or between Group A and Group B. Neither anti-neoplastic nor antibiotic treatment influenced the presence of wound pathogens. Staphylococci were found in 42 %, enteric bacteria in 34 %, anaerobic bacteria in 16 %, Pseudomonas in 10 %, and hemolytic streptococci in 6 % of wounds at baseline; in total, 25 different bacterial species were identified. Sixty-one percent (61 %) of wounds decreased in size following treatment, but no significant differences were observed between the type and variety of wound pathogens and whether wound size decreased. Although quantitative bacteriological changes may have occurred, the possible anti-bacterial effect of the honey or silver dressing could not be confirmed in these malignant wounds. Routine wound swabbing of malignant wounds is of little value and should be restricted to cases where signs of infection requiring antibiotic intervention are observed or where resistant organisms require special infection control measures.
Swan et al (2011) stated that excessive post-operative drainage following groin and axillary lymphadenectomy may be associated with a prolonged hospital stay and an increased complication rate. The use of fibrin sealant before wound closure may reduce post-operative wound drainage. Consecutive patients undergoing elective groin or axillary lymphadenectomy were randomized to standard wound closure or to having fibrin sealant sprayed on to the wound bed before closure. Post-operative wound drainage, duration of drainage and complications were recorded, as were loco-regional recurrence, distant metastasis and mortality. A total of 74 patients requiring 38 groin and 36 axillary dissections were randomized. The median post-operative wound drainage volume for the groin dissection cohort was 762 (range of 25 to 3,255) ml in the control group and 892 (265 to 2,895) ml in the treatment group (p = 0·704). Drainage volumes in the axillary cohort were 590 (230 to 9,605) and 565 (30 to 1,835) ml in the control and treatment groups respectively (p = 0·217). There was no difference in the duration of drainage or post-operative complication rate between the treatment groups in both the axillary and groin cohorts. Local recurrence, distant metastasis and mortality rates did not differ between the treatment groups. The authors concluded that there was no advantage in using fibrin sealant during elective lymphadenectomy in terms of reducing drainage output or post-operative complication rate.
In a Cochrane review, Dumville et al (2013) compared the effects of hydrocolloid wound dressings with no dressing or alternative dressings on the healing of foot ulcers in people with diabetes. For this first update, in April 2013, these investigators searched the following databases the Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (in-process & other non-indexed citations); Ovid EMBASE; and EBSCO CINAHL. There were no restrictions based on language or date of publication. Published or unpublished RCTs that have compared the effects on ulcer healing of hydrocolloid with alternative wound treatments in the treatment of foot ulcers in people with diabetes were selected for analysis. Two review authors independently performed study selection, risk of bias assessment and data extraction. They included 5 studies (535 participants) in the review: these compared hydrocolloids with basic wound contact dressings, foam dressings, alginate dressings and a topical treatment. Meta-analysis of 2 studies indicated no statistically significant difference in ulcer healing between fibrous-hydrocolloids and basic wound contact dressings: RR 1.01 (95 % CI: 0.74 to 1.38). One of these studies found that a basic wound contact dressing was more cost-effective than a fibrous-hydrocolloid dressing. One study compared a hydrocolloid-matrix dressing with a foam dressing and found no statistically significant difference in the number of ulcers healed. There was no statistically significant difference in healing between an antimicrobial (silver) fibrous-hydrocolloid dressing and standard alginate dressing; an anti-microbial dressing (iodine-impregnated) and a standard fibrous hydrocolloid dressing or a standard fibrous hydrocolloid dressing and a topical cream containing plant extracts. The authors concluded that currently there is no evidence to suggest that any type of hydrocolloid wound dressing is more effective in healing diabetic foot ulcers than other types of dressing or a topical cream containing plant extracts. Decision makers may wish to consider aspects such as dressing cost and the wound management properties offered by each dressing type (e.g., exudate management).
In a Cochrane review, Toon and colleagues (2013) evaluated the risk and benefits of removing a dressing covering a closed surgical incision site within 48 hours permanently (early dressing removal) or beyond 48 hours of surgery permanently with interim dressing changes allowed (delayed dressing removal), on surgical site infection. In July 2013, these investigators searched the following electronic databases: The Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library); Database of Abstracts of Reviews of Effects (DARE) (the Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (in-process & other non-indexed citations); Ovid EMBASE; and EBSCO CINAHL. They also searched the references of included trials to identify further potentially-relevant trials. Two review authors independently identified studies for inclusion. They included all RCTs conducted with people of any age and sex, undergoing a surgical procedure, and who had their wound closed and a dressing applied. They included only trials that compared early versus delayed dressing removal; and excluded trials that included people with contaminated or dirty wounds. These researchers also excluded quasi-randomized studies, and other study designs. Two review authors independently extracted data on the characteristics of the trial participants, risk of bias in the trials and outcomes for each trial. They calculated RR with 95 % CI for binary outcomes and mean difference (MD) with 95 % CI for continuous outcomes. They used RevMan 5 software to perform these calculations. A total of 4 trials were identified for inclusion in this review. All the trials were at high risk of bias; 3 trials provided information for this review. Overall, this review included 280 people undergoing planned surgery. Participants were randomized to early dressing removal (removal of the wound dressing within the 48 hours following surgery) (n = 140) or delayed dressing removal (continued dressing of the wound beyond 48 hours) (n = 140) in the 3 trials. There were no statistically significant differences between the early dressing removal group and delayed dressing removal group in the proportion of people who developed superficial surgical site infection within 30 days (RR 0.64; 95 % CI: 0.32 to 1.28), superficial wound dehiscence within 30 days (RR 2.00; 95 % CI: 0.19 to 21.16) or serious adverse events within 30 days (RR 0.83; 95 % CI: 0.28 to 2.51). No deep wound infection or deep wound dehiscence occurred in any of the participants in the trials that reported this outcome. None of the trials reported quality of life. The hospital stay was significantly shorter (MD -2.00 days; 95 % CI: -2.82 to -1.18) and the total cost of treatment significantly less (MD EUR -36.00; 95 % CI: -59.81 to -12.19) in the early dressing removal group than in the delayed dressing removal group in the only trial that reported these outcomes. The authors concluded that early removal of dressings from clean or clean contaminated surgical wounds appears to have no detrimental effect on outcomes. However, it should be noted that the point estimate supporting this statement was based on very low quality evidence from 3 small RCTs, and the CI around this estimate were wide. Early dressing removal may result in a significantly shorter hospital stay, and significantly reduced costs, than covering the surgical wound with wound dressings beyond the first 48 hours after surgery, according to very low quality evidence from 1 small RCT. The authors stated that further RCTs of low risk of bias are needed to examine if dressings are necessary after 48 hours in different types of surgery and levels of contamination and investigate whether antibiotic therapy influences the outcome.
In a Cochrane review, Dumville et al (2014) examined the effects of various tissue adhesives compared with conventional skin closure techniques for the closure of surgical wounds. In March 2014 for this second update, these investigators searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. They did not restrict the search and study selection with respect to language, date of publication or study setting. Only RCTs were eligible for inclusion. These researchers conducted screening of eligible studies, data extraction and risk of bias assessment independently and in duplicate. They expressed results as random-effects models using mean difference for continuous outcomes and RR with 95 % CI for dichotomous outcomes. They investigated heterogeneity, including both clinical and methodological factors. This second update of the review identified 19 additional eligible trials resulting in a total of 33 studies (2,793 participants) that met the inclusion criteria. There was low quality evidence that sutures were significantly better than tissue adhesives for reducing the risk of wound breakdown (dehiscence; RR 3.35; 95 % CI: 1.53 to 7.33; 10 trials, 736 participants that contributed data to the meta-analysis). The number needed-to-treat for an additional harmful outcome was calculated as 43. For all other outcomes – infection, patient and operator satisfaction and cost – there was no evidence of a difference for either sutures or tissue adhesives. No evidence of differences was found between tissue adhesives and tapes for minimizing dehiscence, infection, patients' assessment of cosmetic appearance, patient satisfaction or surgeon satisfaction. However there was evidence in favor of using tape for surgeons' assessment of cosmetic appearance (mean difference (visual analog scale [VAS] 0 to 100) 9.56 (95 % CI: 4.74 to 14.37; 2 trials, 139 participants). One trial compared tissue adhesives with a variety of methods of wound closure and found both patients and clinicians were significantly more satisfied with the alternative closure methods than the adhesives. There appeared to be little difference in outcome for different types of tissue adhesives. One study that compared high viscosity with low viscosity adhesives found that high viscosity adhesives were less time-consuming to use than low viscosity tissue adhesives, but the time difference was small. The authors concluded that sutures are significantly better than tissue adhesives for minimizing dehiscence. In some cases tissue adhesives may be quicker to apply than sutures. Although surgeons may consider the use of tissue adhesives as an alternative to other methods of surgical site closure in the operating room, they need to be aware that sutures minimize dehiscence. They stated that there is a need for more well designed RCTs comparing tissue adhesives with alternative methods of closure. These trials should include people whose health may interfere with wound healing and surgical sites of high tension.
Fungating wounds arise from primary, secondary or recurrent malignant disease and are associated with advanced cancer. A small proportion of patients may achieve healing following surgical excision, but treatment is usually palliative. Fungating wound management usually aims to slow disease progression and optimize quality of life by alleviating physical symptoms, such as copious exudate, malodor, pain and the risk of hemorrhage, through selection of appropriate dressings and topical agents. In a Cochrane review, Adderley and Holt (2014) evaluated the evidence of the effects of dressings and topical agents on quality of life, and symptoms that impact on quality of life, in people with fungating malignant wounds. For this third update, these investigators searched the Wounds Group Specialised Register in August 2013; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. Eligible studies comprised RCTs or, in their absence, controlled clinical trials (CCTs) with a concurrent control group. Data extraction and risk of bias assessment was undertaken by one review author and checked for accuracy by a second. A total of 4 trials involving 164 people were included. One RCT in women with superficial breast lesions compared 6 % miltefosine solution with placebo and found that miltefosine delayed tumor progression. The study reported that the time to treatment failure was significantly longer in the miltefosine group (median of 56 days) than in the placebo group (median of 21 days) (p value 0.007, log-rank test). A second trial compared topical metronidazole with placebo but the results up to the point of cross-over were not statistically significant. A third trial compared the effect of foam dressings containing silver to foam dressings without silver and found that more patients experienced decreased malodor in the foam with silver group than in the foam alone group (p value=0.049). The fourth trial compared the effect of manuka honey-coated dressings with nano-crystalline silver-coated dressings and found no statistically significant difference with regard to exudate, malodor and wound pain. All trials, however, had methodological limitations. The authors concluded that there is weak evidence from 1 small trial that 6 % miltefosine solution applied topically to people with superficial fungating breast lesions (smaller than 1cm) who have received either previous radiotherapy, surgery, hormonal therapy or chemotherapy for their breast cancer, may slow disease progression. They noted that there is also weak evidence to suggest that foam dressings containing silver may be effective in reducing malodor; and there is insufficient evidence to give a clear direction for practice with regard to improving quality of life or managing wound symptoms associated with fungating wounds. They stated that more research is needed.
Andrew and colleagues (2015) reviewed published RCTs and non-RCTs examining the effect of drains and dressings on wound healing rates and complications in posterior spine surgery. The use of post-operative drains and the type of post-operative dressing is at the discretion of the treating surgeon with no available clinical guidelines. Drains will theoretically decrease incidence of post-operative hematoma and therefore, potentially decrease the risk of neurologic compromise when the neural elements have been exposed. Occlusive dressings have more recently been advocated, potentially maintaining a sterile barrier for longer time periods post-operatively. A systematic review of databases from 1969 to 2013 was undertaken. All papers examining drains in spine surgery and dressings in primary healing of surgical wounds were included. Revman (version 5.2; The Nordic Cochrane Centre, The Cochrane Collaboration, Oxford, UK) was used to test for overall treatment effect, clinical heterogeneity and risk of bias. Of the papers identified, 1,348 examined post-operative drains in spine surgery and 979 wound dressings for primary wound healing of all surgical wounds. A total of 7 studies were included for analysis for post-operative drains and 10 studies were analyzed for primary wound healing. The use of a post-operative drain did not influence healing rates and had no effect secondarily on infection (odds ratio [OR] 1.33; 95 % CI: 0.76 to 2.30). These researchers were not able to establish whether surgical drains prevent hematomas causing neurologic compromise. There was a slight advantage to using occlusive dressings versus non-occlusive dressings in wound healing (OR 2.09; 95 % CI: 1.44 to 3.02). Incisional vacuum dressings as both an occlusive barrier and superficial drainage system have shown promise for wounds at risk of dehiscence. There is a relatively high risk of bias in the methodology of many of the studies reviewed. The authors recommended favoring of occlusive dressings based on heterogeneous and potentially biased evidence. They stated that drain use does not affect wound healing based on similar evidence; and incisional vacuum dressings have shown promise in managing potentially vulnerable wounds.
Dialkylcarbamoyl Chloride (DACC)-Coated Dressings for Surgical Site Infection
Totty and associates (2017) noted that dialkylcarbomoyl chloride (DACC)-coated dressings (Leukomed Sorbact and Cutimed Sorbact) irreversibly bind bacteria at the wound surface that are then removed when the dressing is changed. They are a recent addition to the wound care professional's armamentarium and have been used in a variety of acute and chronic wounds. These researchers evaluated the evidence supporting the use of DACC-coated dressings in the clinical environment. They included all reports of the clinical use of DACC-coated dressings in relation to wound infection. Medline, Embase, CENTRAL and CINAHL databases were searched to September 2016 for studies evaluating the role of DACC-coated dressings in preventing or managing wound infections. These investigators identified 17 studies with a total of 3,408 patients that were included in this review. The DACC-coating was suggested to reduce post-operative surgical site infection (SSI) rates and resulted in chronic wounds that subjectively looked cleaner and had less bacterial load on microbiological assessments. The authors concluded that existing evidence for DACC-coated dressings in managing chronic wounds or as a SSI prophylaxis was limited but encouraging with evidence in support of DACC-coated dressings preventing and treating infection without adverse effects.
Silver-Containing Dressing for Surgical Site Infection
Dumville and colleagues (2016) stated that surgical wounds (incisions) heal by primary intention when the wound edges are brought together and secured, often with sutures, staples, or clips. Wound dressings applied after wound closure may provide physical support, protection and absorb exudate. There are many different types of wound dressings available and wounds can also be left uncovered (exposed); SSI is a common complication of wounds and this may be associated with using (or not using) dressings, or different types of dressing. In a Cochrane review, these investigators examined the effects of wound dressings compared with no wound dressings, and the effects of alternative wound dressings, in preventing SSIs in surgical wounds healing by primary intention. They searched the following databases: the Cochrane Wounds Specialised Register (searched September 19, 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library 2016, Issue 8); Ovid Medline (including In-Process & Other Non-Indexed Citations, MedlineE Daily and Epub Ahead of Print; 1946 to September 19, 2016); Ovid Embase (1974 to September 19, 2016); EBSCO CINAHL Plus (1937 to September 19, 2016). There were no restrictions based on language, date of publication or study setting; RCTs comparing wound dressings with wound exposure (no dressing) or alternative wound dressings for the post-operative management of surgical wounds healing by primary intention. Two review authors performed study selection, “risk of bias” assessment and data extraction independently. These researchers included 29 trials (5,718 participants). All studies except 1 were at an unclear or high risk of bias. Studies were small, reported low numbers of SSI events and were often not clearly reported. There were 16 trials that included people with wounds resulting from surgical procedures with a “clean” classification, 5 trials that included people undergoing what was considered “clean/contaminated” surgery, with the remaining studies including people undergoing a variety of surgical procedures with different contamination classifications; 4 trials compared wound dressings with no wound dressing (wound exposure); the remaining 25 studies compared alternative dressing types, with the majority comparing a basic wound contact dressing with film dressings, silver dressings or hydrocolloid dressings. The review contained 11 comparisons in total. It was uncertain whether wound exposure or any dressing reduced or increased the risk of SSI compared with alternative options investigated: these researchers assessed the certainty of evidence as very low for most comparisons (and low for others), with down-grading (according to GRADE criteria) largely due to risk of bias and imprecision. They summarized the results of comparisons with meta-analyzed data below: film dressings compared with basic wound contact dressings following clean surgery (RR 1.34, 95 % CI: 0.70 to 2.55), very low certainty evidence down-graded once for risk of bias and twice for imprecision. Hydrocolloid dressings compared with basic wound contact dressings following clean surgery (RR 0.91, 95 % CI: 0.30 to 2.78), very low certainty evidence down-graded once for risk of bias and twice for imprecision. Hydrocolloid dressings compared with basic wound contact dressings following potentially contaminated surgery (RR 0.57, 95 % CI: 0.22 to 1.51), very low certainty evidence down-graded twice for risk of bias and twice for imprecision. Silver-containing dressings compared with basic wound contact dressings following clean surgery (RR 1.11, 95 % CI: 0.47 to 2.62), very low certainty evidence down-graded once for risk of bias and twice for imprecision. Silver-containing dressings compared with basic wound contact dressings following potentially contaminated surgery (RR 0.83, 95 % CI: 0.51 to 1.37), very low certainty evidence down-graded twice for risk of bias and twice for imprecision. There was limited and low or very low certainty evidence on secondary outcomes such as scarring, acceptability of dressing and ease of removal, and uncertainty whether wound dressings influenced these outcomes. The authors concluded that it was uncertain whether covering surgical wounds healing by primary intention with wound dressings reduced the risk of SSI, or whether any particular wound dressing was more effective than others in reducing the risk of SSI, improving scarring, reducing pain, improving acceptability to patients, or was easier to remove. They stated that most studies in this review were small and at a high or unclear risk of bias. They noted that based on the current evidence, decision makers may wish to base decisions about how to dress a wound following surgery on dressing costs as well as patient preference.
Li and colleagues (2017) noted that silver-containing dressings for the prevention of surgical site infections (SSIs) remained controversial, and accumulating evidence was lacking, so a meta-analysis was conducted to systematically assess the safety and effectiveness of silver-containing dressings for clean and clean-contaminated surgical incisions. PubMed, Embase, and the Cochrane Library were searched from the inception to February 2016 for RCTs, which explored silver-containing dressings for the prevention of SSIs in clean and clean-contaminated operations; RR with 95 % CI was pooled using random effects model. Pre-defined subgroup analyses, sensitivity analyses, and influence analyses were further undertaken. A total of 9 RCTs totaling 2,196 patients (1,141 in silver-containing group and 1,055 in control group) were included. Silver-containing dressings did not effectively prevent the incidence of SSIs (9 RCTs; RR: 0.92; 95 % CI: 0.66 to 1.29; I2 = 40 %), superficial SSIs (5 RCTs; RR: 0.67; 95 % CI: 0.36 to 1.24; I2 = 36 %), and deep SSIs (5 RCTs; RR: 0.78; 95 % CI: 0.41 to 1.49; I2 = 0). Subgroup analyses, sensitivity analyses, and influence analyses confirmed the robustness of the pooled estimate. The authors concluded that the current available evidence indicated that silver-containing dressing as compared with silver-free dressing was not associated with lower incidence of SSIs. Moreover, they stated that considering the quality of evidence ranking very low, further studies with higher quality are needed.
Negative Pressure Dressings for Open Fractures
Costa and colleagues (2018) stated that open fractures of the lower limb occur when a broken bone penetrates the skin. There can be major complications from these fractures, which can be life-changing. In a multi-center, randomized study, these investigators examined the disability, rate of deep infection, and quality of life (QOL) in patients with severe open fracture of the lower limb treated with negative pressure wound therapy (NPWT) versus standard wound management after the first surgical debridement of the wound. Thus trial was performed in the United Kingdom (UK) Major Trauma Network, recruiting 460 patients aged 16 years or older with a severe open fracture of the lower limb from July 2012 through December 2015. Final outcome data were collected through November 2016. Exclusions were presentation more than 72 hours following injury and inability to complete questionnaires. Interventions were NPWT (n = 226) in which an open-cell solid foam or gauze was placed over the surface of the wound and connected to a suction pump, creating a partial vacuum over the dressing, versus standard dressings not involving application of negative pressure (n = 234). Disability Rating Index score (range of 0 [no disability] to 100 [completely disabled]) at 12 months was the primary outcome measure, with a minimal clinically important difference of 8 points. Secondary outcomes were complications including deep infection and QOL (score ranged from 1 [best possible] to -0.59 [worst possible]; minimal clinically important difference, 0.08) collected at 3, 6, 9, and 12 months. Among 460 patients who were randomized (mean age of 45.3 years; 74 % men), 88 % (374/427) of available study subjects completed the trial. There were no statistically significant differences in the patients' Disability Rating Index score at 12 months (mean score of 45.5 in the NPWT group versus 42.4 in the standard dressing group; mean difference, -3.9 [95 % CI: -8.9 to 1.2]; p = 0.13), in the number of deep surgical site infections (16 [7.1 %] in the NPWT group versus 19 [8.1 %] in the standard dressing group; difference, 1.0 % [95 % CI: -4.2 % to 6.3 %]; p = 0.64), or in QOL between groups (difference in EuroQol 5-dimensions questionnaire, 0.02 [95 % CI: -0.05 to 0.08]; Short Form-12 Physical Component Score, 0.5 [95 % CI: -3.1 to 4.1] and Mental Health Component Score, -0.4 [95 % CI: -2.2 to 1.4]). The authors concluded that among patients with severe open fracture of the lower limb, the use of NPWT compared with standard wound dressing did not improve self-rated disability at 12 months; these findings did not support negative pressure dressings for the treatment of severe open fractures.
National Institute for Health Research (NIRH) Signal’s technology assessment on “Negative pressure dressings are no better than standard dressings for open fractures” (2018) stated that open fractures of the leg, where the broken bone is exposed by the original injury or has burst through the skin, are prone to infection. Usually, the wound is thoroughly cleaned, damaged tissue debrided, the bone stabilized and a standard dressing applied; NPWT requires a special dressing and an additional vacuum pump. This removes surplus blood and fluid from the wound, which was expected to improve the chances of healing and reduce deep tissue infections. The NIHR assessment stated that negative pressure wound dressings are neither more nor less effective than standard wound dressings for severe open fractures of the lower leg. Any difference between groups was neither clinically important nor statistically significant. The outcomes included self-rated disability at 1 year, QOL and deep surgical site infections at 1 month that occurred in around 7 to 8 % in each group. The results of this NIHR-funded trial suggested that this more expensive option offered no significant gains for patients.
Tamponade Dressings Following Open Hemorrhoidectomy
Langenbach and colleagues (2014) stated that bleeding following hemorrhoidectomy is common. Many surgical textbooks recommend insertion of an anal tampon in order to reduce post-operative bleeding. This practice, however, is bothersome and probably painful for patients. The effect of using a tamponade has not been validated in RCTs. In a pilot study with 100 patients who were scheduled for Milligan-Morgan hemorrhoidectomy, these investigators examined whether the insertion of an anal tamponade would reduce post-operative bleeding. During surgery, patients were randomly assigned to receive or not to receive an anal tampon at the end of the procedure. Data on pain, complications and wound care were collected. There were 48 patients in the group with tamponade, and 52 patients were left without tamponade. The trial's primary outcome and maximum pain intensity, averaged 6.1 and 4.2 in the 2 groups (p = 0.001). In the group with tamponade, a complication was recorded in 7 patients (15 %), which was similar to the group without tamponade (21 %). Severe anal bleeding occurred in 2 and 5 patients, respectively. Bandage changes were less necessary often in the group treated without tamponade (p = 0.013); hospital stay was 4 days in both groups. The authors concluded that the findings of this study indicated that insertion of an anal tampon following hemorrhoidectomy did not reduce post-operative bleeding; but caused significantly more pain. These investigator stated that following hemorrhoidectomy, anal tampons should not be used routinely but may be considered when specific indications justify its use.
Langenbach and Seidel (2019) noted that symptomatic hemorrhoids are one of the most common anorectal disorders. Many surgeons use tamponades following open hemorrhoidectomy to manage post-operative bleeding. The question of whether a tamponade is necessary and beneficial following hemorrhoidectomy has not yet been conclusively answered. A previously conducted single-center, pilot trial (Langenbach et al, 2014) included 100 patients following Milligan-Morgan hemorrhoidectomy. The data indicated that insertion of an anal tamponade following hemorrhoidectomy did not reduce post-operative bleeding but caused significantly more pain. The findings of this pilot trial are now to be verified by means of a multi-center randomized clinical study called NoTamp. These researchers plan to include 953 patients following Milligan-Morgan or Parks hemorrhoidectomy in the NoTamp study. The aim is to demonstrate that using no tamponade dressing after open hemorrhoidectomy is not inferior to using tamponades with respect to post-operative bleeding, and that the patients report less pain. Primary end-points of the trial are the maximum post-operative pain within 48 hours and the incidence of severe post-operative bleeding that requires surgical revision within 7 days after the surgical procedure. Secondary end-points of the study are the use of analgesics in the post-operative course, the lowest hemoglobin (Hb) documented within 7 days, QOL and patient satisfaction. Safety analysis includes all adverse and serious adverse events (AEs) in relation to the study treatment. The authors concluded that this study received full ethics committee approval; the first patient was enrolled on May 3, 2017. This trial will finally answer the question whether the insertion of a tamponade following open hemorrhoidectomy is necessary and beneficial.
OxyBand Wound Dressing
OxyBand Wound Dressing, cleared via the 510(k) process, provides oxygen to wounds for up to 5 days. The oxygen, pre-packaged and in a proprietary method, diffused into the patented reservoir system inside of the OxyBand Wound Dressing. The pre-filled multi-layer, OxyBand Wound Dressing, comes pre-filled with high levels of oxygen between the layers. OxyBand Wound Dressing incorporates a barrier layer that holds the oxygen in the vicinity of the wound, and a permeable or porous layer that allows oxygen to diffuse into the wound. The dressing acts like an oxygen reservoir allowing the wound to utilize as much oxygen as needed, and continues to supply oxygen on demand to the wound as the wound consumes oxygen from the wound fluid.
Lairet and colleagues (2014) noted that accelerating the healing process and reducing pain during healing are beneficial for the following reasons: faster return to work, lower risk of wound infection, improved quality of life (QOL), and possibly reduced need for analgesia. In a prospective RCT, these researchers examined the effectiveness of a new oxygen-diffusion dressing (OxyBand; Oxyband Technologies, St. Louis, MO) compared with standard Xeroform gauze dressings (Convidien, Mansfield, MA), in the care of skin-graft donor sites in burn patients. Time to healing was the primary end-point, and pain scores and cosmetic outcome were also assessed.
This study included burn patients undergoing harvesting of 2 donor sites. Patients were followed at pre-determined time-points for 30 to 45 days to determine the time to re-epithelialization, cosmetic appearance, and pain. Subjects were adult burn patients with less than 30 % total body surface area (TBSA) burns admitted to the burn center, who needed excision and grafting. A total of 20 patients were enrolled, of whom 17 completed the study. Average age was 35 years; average burn size was 9.2 % TBSA. Patients underwent harvesting of split-thickness skin grafts with 1 donor wound dressed with OxyBand and the other dressed in Xeroform gauze. Wounds were inspected and photographed on post-operative days 4 and 8, and then every 2 days until the donor wounds were healed. Pain scores at each site were also collected at these visits (rated by patients on a scale from 0 to 10). Mean time to wound healing for OxyBand was 9.3 ± 1.7 days; for Xeroform, 12.4 ± 2.7 days (p < 0.001). Pain scores were lower (p < 0.01) at the OxyBand site compared with the Xeroform site at all time-points during post-operative days 4 to 12. There was no difference in the cosmetic outcome of the wounds at 30 to 45 days post-operatively. The authors concluded that the findings of this study showed a decrease in the time to healing and in pain at donor sites dressed with an oxygen-diffusion dressing. This was a small study (n = 17 subjects who completed the study); these preliminary findings need to be validated by well-designed studies.
In a review on "Treating pain on skin graft donor sites", Sinha and associates (2017) noted that split-thickness skin grafting is the most common reconstructive procedure in managing burn injuries. Harvesting split-thickness skin creates a new partial thickness wound referred to as the donor site. Pain at the donor site is reported to be one of the most distressing symptoms during the early post-operative period. These investigators identified strategies for managing donor site pain, assessed the quality of individual studies, and formulated evidence-based recommendations based on the amount and consistency of evidence. Their analysis revealed 5 distinct approaches to minimize donor site pain. These included: continuous subcutaneous local anesthetic infusion (3 studies), subcutaneous anesthetic injection (5 studies), topical agents (6 studies), non-pharmacological interventions (3 studies), and wound dressings (18 studies). Available RCTs typically evaluated pain on standardized scales (i.e., VAS, numerical rating scale [NRS]), and compared the experimental group with standard care. Recommended treatments included: subcutaneous anesthetic injection of adrenaline-lidocaine; ice application; topical agents, such as lidocaine and bupivacaine; and hydrocolloid- and polyurethane-based wound dressings accompanied with fibrin sealant. The authors concluded that methodologically sound RCTs examining the efficacy of modified tumescent solution, ropivacaine, plasma therapy, non-contact ultrasound, and morphine gels are lacking and should be a priority for future research. This review did not mention the use of oxygen-diffusion dressing.
Chlorhexidine-Impregnated Wound Dressing for the Prophylaxis of Central Venous Catheter-Related Complications
Wei and colleagues (2019) noted that several RCTs examined the role of chlorhexidine-impregnated dressing for prophylaxis of central venous catheter (CVC)-related complications; however, the results remained inconsistent, updated meta-analyses on this issue are needed. These researchers carried out a meta-analysis on the RCTs comparing chlorhexidine-impregnated dressing versus other dressing or no dressing for prophylaxis of CVC-related complications. A comprehensive search of major data-bases was conducted up to December 30, 2018 to identify related studies. Pooled OR and MDs with 95 % CI were calculated using either a fixed-effects or random-effects model. Subgroup analysis was performed to identify the source of heterogeneity, and funnel plot and Egger test was used to identify the publication bias. A total of 12 RCTs with 6,028 participants were included. The chlorhexidine-impregnated dressings provided significant benefits in reducing the risk of catheter colonization (OR = 0.46, 95 % CI: 0.36 to 0.58), decreasing the incidence of catheter-related bloodstream infection (CRBSI) (OR = 0.60, 95 % CI: 0.42 to 0.85). Subgroup analysis indicated that the chlorhexidine-impregnated dressings were conducive to reduce the risk of catheter colonization and CRBSI within the included RCTs with sample size more than 200, but the differences weren't observed for those with sample less than 200. No publication bias was observed in the Egger test for the risk of CRBSI. The authors concluded that chlorhexidine-impregnated dressing was beneficial to the prevention of CVC-related complications. Moreover, these researchers stated that future studies are needed to examine the role and cost-effectiveness of chlorhexidine-impregnated dressings.
The authors stated that this meta-analysis had several drawbacks. First, these investigators didn’t use mesh terms in their search strategy or ask for help from a librarian developing the search strategy; thus, it was possible that some articles might have been missed in their initial search. Second, considering the nature of intervention, it was difficult to blind the research personnel and outcome assessment, none of included RCTs was truly double-blinded design, hence the risk of bias was inevitable; and the blood culture was conducted in elected patients only among the included RCTs, this might also have introduced bias. Third, the rates of CRBSI among included RCTs varied greatly with a range of 0 to 11.3 %, it might be related to the differences in clinical nursing practice and guidelines. Fourth, the Egger test for the detection of publication bias was potentially under-powered given the small sample size, a non-significant Egger’s test did not necessarily suggest lack of asymmetry in the Funnel plot, therefore, these findings should be treated with cautions. Finally, these researchers only made post-hoc subgroup analyses stratified by sample size, but not by insertion location, type of chlorhexidine-impregnated dressing, the frequency of dressing changes etc. due to the data limitation, the publication bias on the risk of catheter colonization remained unclear. These investigators stated that f future studies addressing the role of chlorhexidine-impregnated dressing with combined consideration to those related factors are needed.
The Centers for Disease Control and Prevention (Talbot et al, 2017) recommends chlorhexidine-impregnated dressings with an FDA-cleared label that specifies a clinical indication for reducing catheter-related bloodstream infection (CRBSI) or catheter-associated blood stream infection (CABSI) to protect the insertion site of short-term, nontunneled central venous catheters in adults.
Colovac Endoluminal Bypass Sheath for Colorectal Resection
On June 8, 2024, the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to investigate the use of Colovac, an endoluminal bypass sheath, intended as a less-invasive alternative to temporary diverting ostomy for patients undergoing colorectal resection. The Colovac device is secured above the anastomosis using a stent combined with a novel vacuum-based mechanism. Once the device is implanted, it covers the colon down to the anus. Temporary diverting ostomy is the current standard of care for patients in this setting and is performed prophylactically for most patients who require low anterior resection (LAR) or anastomosis (SafeHeal, 2025b).
Colovac is designed to function as a colorectal anastomosis protection device to reduce the contact of fecal content at the anastomotic site following colorectal surgery. Device placement occurs at the time of rectal resection surgery and is fully reversible. Colovac stays in place for 10 days to allow the body's natural healing and repair processes to complete, and then it is removed endoscopically without requiring a second surgical intervention (SafeHeal, 2025a).
D'Urso, Komen, and Lefevre (2020) conducted a first-in-human study examining the safety and preliminary efficacy of Colovac, anastomosis protection device. The Colovac device consists of a flexible bypass sheath, placed in the lume of the colon and is anchored above the anastomosis using a vacuum stent.
In this study, 15 patients underwent laparoscopic anterior resection with Colovac placement at 3 European centers. Examination of anastomosis integrity occurred after 14 days by computed tomography (CT) scan and endoscopy. The device was then retrieved endoscopically.
The investigators prospectively collected data consisting of demographics, surgical details, 30 day post-operative complications, and patient satisfaction. Out of the 15 patients, 54% received preoperative neoadjuvant therapy. Endoscopic device removal was determined to be easy or very easy in 87% of the cases. Fecal absence below the Colovac anchoring site was noted in 100% of the cases and 4 anastomotic leakages were noted (including 3 device migrations). In total, 5 patients (33%) needed a planned stoma creation. At 3 months, 1 had already closed.
The investigators concluded that Colovac offers a minimally invasive protection of the anastomosis during the healing process by not requiring a diverting ostomy for two-thirds of patients who will not experience anastomotic complications and allowing safe conversion to the standard of care for patients requiring extended anastomotic protection. A larger study is underway to confirm these results.
De Hous et al. (2022) conducted a study to evaluate the preliminary efficacy, safety, and technical feasibility of the Colovac+ in a porcine model. Twelve pigs received a colorectal anastomosis with Colovac+ implantation. The device remained in situ for 10 days and then was removed endoscopically.
The investigators performed clinical, endoscopic, and histopathological examinations to assess the following endpoints: prevention of contact between the anastomosis and fecal content, device migration, feasibility of the implantation and retrieval procedure, collateral damage to the colonic wall, colon healing after device retrieval, and systemic toxicity related to the device.
Eleven pigs completed the study and one pig died prematurely due to a surgical complication unrelated to the device (bladder damage with uroperitoneum). The findings showed no evidence of contact between the anastomosis and fecal content, no development of symptomatic anastomotic leakage, and no significant device migrations, and no evidence of systemic toxicity. Colovac+ was easily implanted in all cases except 1 (due to an inappropriate lubricant) and successfully removed in all cases. Postremoval evaluations on day 10 showed ulcerations at the anchoring site in 4 cases indicating mechanical damage caused by the stent. In the recovery group, no ulcerations were noted on day 38, and the colonic wall had appropriately healed in all animals.
The investigators concluded Colovac+ is a technically feasible, safe, and efficient device for the protection of a colorectal anastomosis in a porcine model. Colovac+ shows promise for clinical application and warrants more research.
De Hous et al. (2023) conducted a clinical trial to evaluate the preliminary efficacy and safety of the Colovac+. Colovac+, a second version of Colovac, was developed to reduce the migration risk during the implantation period. This prospective, multicenter, pilot study enrolled 25 patients undergoing LAR of whom 15 were consecutively treated with Colovac+and Vacuum Loss Alert System. A computed tomography (CT) scan was performed after 10 days for anastomosis evaluation and the Colovac+ was removed endoscopically in 14/15 (93%) patients.
The primary endpoint was the rate of major (Clavien-Dindo III-V) postoperative complications related to the Colovac+ or LAR procedure.
The overall major postoperative morbidity rate was 40%, but none of the reported complications were related to the Colovac+. Device migration was observed in 2 (13%) patients, but these were not associated with anastomotic leakage (AL) or stoma conversion. In general, the Colovac+ provided effective fecal diversion in all 15 patients and was able to avoid the protective ileostomy in 11/15 (73%) of patients. The investigators also noted the improved design of the Colovac+ reduced the overall migration rate and limited the clinical impact of a migration.
Continuous Combined Positive and Negative Pressure Dressing in the Treatment of Auricular Seroma
Shalini et al (2025) noted that auricular seroma is a benign ear condition characterized by the accumulation of sterile serous fluid between the perichondrium and auricular cartilage. It presents as a painless, solitary or diffuse, and fluctuant swelling; its diagnosis relies on these distinctive features. Treatment of this condition is challenging due to its high recurrence rate. Medical therapies have limited success, making surgery the preferred option. However, even invasive surgical procedures such as incision and drainage or aspiration often result in a high recurrence rate. In a prospective study, these researchers examined the effectiveness of combined positive and negative pressure dressing in the treatment of patients with auricular seroma. Patients aged over 18 years with symptoms suggestive of auricular seroma were enrolled in in this trial for a period of 6 months (January 2024 to June 2024). Upon confirmation, participants underwent aspiration followed by combined positive and negative pressure dressing on outpatient basis. A total of 30 patients were enrolled in this trial. All subjects presented with auricular swelling, predominantly unilateral disease. Higher incidence in males was noted. The most common etiology was idiopathic. None of the subjects had recurrence during the 3-month follow-up period. Complications such as pain or ear disfigurement were not observed in any of the subject during the follow-up. The authors concluded that continuous combined positive and negative pressure dressing was a simple, non-invasive and cost-effective treatment that showed promise in preventing recurrence of auricular seroma. These preliminary findings need to be validated by well-designed studies.
Wound Dressings for Hip and Knee Surgeries
In a RCT, Srivastava et al (2025) examined the effectiveness of 3 advanced wound dressings (Aquacel Ag, Opsite Post-Op, and Mepilex Border Post-Op) versus traditional dressings in post-operative care for patients undergoing hip or knee surgeries. This trial was carried out between August and December 2022 at a tertiary care orthopedic centre. A total of 314 patients were randomized into 4 groups. Group A received Aquacel Ag, Group B received Opsite Post-Op, Group C received Mepilex Border Post-Op, and Group D received traditional dressings. The primary outcomes measured were pain levels during dressing changes, exudate management, patient comfort, nurses' ease of application and removal of the dressing, as well as surgical site complications. Multi-variate analysis, including logistic regression, was carried out to adjust for potential confounders. Mepilex Border Post-Op (Group C) significantly out-performed other dressings in key areas. Pain levels during dressing changes were consistently lower in this group on Day 3 (3.5 ± 0.8 versus 6.0 ± 1.1 in the traditional dressing group, p = 0.002); and at day 7 and 14 as well. Exudate management was effective with Mepilex Border Post-Op. Group C patients reported the highest comfort and mobility scores on a Likert scale with easy application and removal. Surgical site complications were minimal, with only 1.2 % of Group C patients affected by Day 14 compared to 9.8 % in Group D (p = 0.003). Multi-variate analysis confirmed that Mepilex Border Post-Op significantly lowered surgical site complications and improved patient comfort, with adjusted ORs favoring this dressing over traditional options. The authors concluded that Mepilex Border Post-Op (a 4-layer hydrophilic foam dressing) exhibited benefits in post-operative care, reducing pain and complications while improving patient comfort. Moreover, these researchers stated that single-center design with a limited sample size of this trial limited the generalizability of these findings; they stated that further investigations are needed to confirm these findings in broader clinical settings.
CLR Irrigator
The CLR Irrigator is a medical device for thoracic irrigation, used to deliver warm saline and suction fluid from a patient's chest cavity through an indwelling chest tube. It enables a single-handed, sterile, and seamless method for treating conditions like complicated pleural infections and hemothorax by helping to clear fluid, debris, and blood from the pleural space. The device connects to standard spikable fluid bags and wall suction, and works with a specialized CLR Port, which provides secure and repeated access for irrigation without disrupting the drainage circuit.
Uribe, et al. (2025) stated that pleural infections are a significant cause of morbidity and mortality, particularly in elderly patients and those with comorbidities who are often unsuitable for surgery. Treatment typically involves antibiotics and drainage, but in approximately 30% of cases, loculations and increased fluid viscosity hinder effective drainage. Intrapleural enzymatic therapy (IET) with tissue plasminogen activator (tPA) and DNase improves drainage but carries a bleeding risk, especially in patients with coagulopathies. Uribe, et al. (2025) reported a study investigating the use of the CLR Irrigator as a safer alternative for patients with contraindications to IET. The investigators retrospectively reviewed four patients with complicated pleural infections contraindicated for IET due to concurrent anticoagulation, recent hemorrhage, or coagulopathy. Each patient underwent ultrasound-guided placement of a 14 French chest tube. The CLR Irrigator was used to instill warm saline (100–500 mL) into the pleural space, followed by alternating cycles of irrigation and suction. Irrigation sessions were performed daily until clinical improvement. Chest CT scans were obtained pre- and post-irrigation to evaluate changes in pleural effusion. The investigators reported that thoracic irrigation was well tolerated in all cases, with a median chest tube duration of 4 days (range: 1-9 days). Significant radiographic improvement in pleural opacity was observed across all patients. No major adverse events occurred, though one patient experienced saline leakage around the CLR port and another reported transient chest discomfort. None required further pleural intervention. Clinical improvement was achieved in all patients. The investigators concluded that the CLR Irrigator provided a safe and effective alternative to IET in managing complicated pleural infections, particularly in patients with bleeding risks or contraindications to surgery. This method allows precise control of irrigation and drainage, leading to rapid clinical and radiographic improvement. The investigators stated that further prospective studies are warranted to validate these findings and to explore the potential of the CLR Irrigator as a standard therapeutic option in pleural infections, either as a standalone therapy or in combination with other treatments.
Belt & Schwalk (2025) reported a case of successful pleural drainage via chest tube and pleural irrigation with the CLR Irrigator in a patient with a loculated and potentially infected malignant effusion. The patient was a 79 year old male with a history of metastatic pancreatic cancer complicated by left-sided malignant pleural effusion and prior pulmonary embolism on apixaban who presented with progressive shortness of breath and cough. CT chest showed a large, loculated left-sided pleural effusion with associated mass effect. A small-bore chest tube was placed with partial fluid drainage. Cell count revealed 1,730 nucleated cells (55% polys and 13% lymphs) and 480,000 RBCs. It was exudative by Light's criteria with an LDH 1395 U/L and protein of 4.7 g/dL. Glucose level was 42 and pH was 7.32. Given incomplete drainage and persistent symptoms, the investigators performed pleural irrigation with sterile saline utilizing the CLR irrigation kit. About 800 mL of warm sterile saline was used for irrigation and approximately 1.5 L of sanguinous appearing fluid was drained. Chest x-ray after irrigation demonstrated significant improvement in the pleural fluid collections. The patient also experienced symptomatic improvement. The chest tube was removed, and he was discharged home to complete a course of empiric antibiotics with plans for outpatient tunneled pleural catheter placement. The investigators reported that, to their knowledge, this is the first time the CLR pleural irrigation system had been used for drainage of a loculated, malignant pleural effusion. Thoracic irrigation has been used for traumatic hemothorax and reduced the need for secondary intervention for retained hemothorax. Similarly, malignant effusions can be difficult to drain with tube thoracostomy if the pleural fluid is hemorrhagic and/or infected with associated loculations. Intrapleural fibrinolytic therapy can be used but carries a small risk of pleural bleeding and it is unknown if this risk is increased if the effusion is already bloody as in this patient. The investigators concluded that pleural irrigation is a safe option that could help facilitate successful drainage and reduce the need for intrapleural fibrinolytics or surgical intervention.
Seadler, et al. (2025) used a swine model to compare the CLR Irrigator's effectiveness with different tube sizes. The study found that larger 28 Fr chest tubes resulted in less retained hemothorax volume after irrigation compared to smaller 14 Fr pigtail catheters.
As of mid-2025, a pilot clinical trial (NCT06937450) was underway for the CLR Irrigator in trauma patients. The study aims to evaluate the impact of tube size and daily lavage on hemothorax outcomes, with a primary endpoint of comparing the need for additional interventions versus historical control groups.
MY01 Continuous Compartment Pressure Monitor
The MY01 Continuous Compartment Pressure Monitor (MY01, Inc.) is a medical device designed to provide real-time, continuous monitoring of muscle compartment pressure to aid in the diagnosis of acute compartment syndrome (ACS). It features an indwelling sensor that is inserted into a muscle compartment and transmits data wirelessly to a mobile application, allowing clinicians to visualize pressure trends over time. This objective data helps physicians decide when to intervene with a fasciotomy, complementing traditional, often subjective, clinical assessments and avoiding both missed diagnoses and unnecessary procedures. In October 2021, the device received Breakthrough Device designation from the FDA, and it has since received 510(k) clearance.
A preclinical study (Merle, et al, 2020) compared the MY01 with the Synthes and Stryker devices, which are more traditional pressure-measuring instruments. In a rat model of abdominal compartment syndrome, the MY01 was over 600% more accurate than the other devices in tracking pressure changes.
Data from a clinical trial presented at the Orthopaedic Trauma Association Annual Meeting (MYO1, 2022) demonstrated that using the MY01 monitor as a complement to clinical signs enabled accurate diagnosis of all ACS cases in patients with upper or lower extremity fractures. No cases were missed, and there were no false positives.
A case study (Montreuil, et al., 2022) described the use of the MY01 device in three patients. The device helped detect early-stage ACS and expedite surgery for two patients, while objectively ruling out a suspected diagnosis in another, thus preventing an unnecessary fasciotomy.
A study (Suddith & Whitford, 2024) highlighted the value of the MY01 in patients on mechanical circulatory support (MCS), who are often difficult to assess for ACS. In four case studies, the device helped augment clinical diagnosis, prompting timely fasciotomies without any reported complications at the insertion site despite anticoagulation use.
Clinical Trials of MY01 are currently ongoing, including a study evaluating the device as an aid for diagnosing acute compartment syndrome in patients at risk (NCT04016103), a study assessing the safety and functionality of the device in patients with an upper or lower extremity fracture at risk for ACS (NCT04012723), and a multi-center prospective trial enrolling 50 participants to document the device's clinical benefit (NCT04671173).
Juveena Hydrogel System
The Juveena Hydrogel System is an investigational medical device developed by Rejoni, Inc. for use in women’s health, particularly to prevent intrauterine adhesions (IUAs) and to manage heavy menstrual bleeding (HMB). It consists of a proprietary transcervical catheter and two liquid precursors that, when instilled into the uterus, form a soft hydrogel. This hydrogel is over 90% water and includes polyethylene glycol (PEG) as a key component. Once inside the uterine cavity, the hydrogel acts as a temporary physical barrier, keeping the uterine walls apart during healing and thereby reducing the risk of adhesions. It naturally dissolves and exits the body within two to three weeks, eliminating the need for removal. The system is currently undergoing clinical trials (NCT05394662) to evaluate its safety and effectiveness for both adhesion prevention following gynecologic procedures and for temporary control of chronic ovulatory HMB. It is not yet FDA-approved but is being actively studied in feasibility and pivotal trials.
Percutaneous Tissue Displacement Procedures
A percutaneous tissue displacement procedure is a minimally invasive technique used to safely move or separate internal body structures with the aid of imaging. Common methods for displacing tissue include hydrodissection, pneumodissection, and specialized gels and balloons.
For hydrodissection, several RCTs have been conducted, particularly in the context of nerve entrapment syndromes such as carpal tunnel syndrome. For example, a randomized controlled trial compared ultrasound-guided triamcinolone acetonide hydrodissection to perineural corticosteroid injection alone in carpal tunnel syndrome and found that both groups improved, but hydrodissection did not provide additional benefit over perineural injection alone (Wang, et al., 2021). A systematic review identified six RCTs of hydrodissection for carpal tunnel syndrome, confirming that the procedure is safe but that its specific clinical benefit over standard injection techniques remains unclear (Neo, et al., 2022).
For other uses of hydrodissection, such as in ablation of hepatic tumors, available studies are retrospective (Liu, et al., 2021). Similarly, studies of hydrodissection in surgical or interventional settings (e.g., prostatectomy, peritoneal navigation) are either retrospective, experimental, or small pilot studies (Asimakopoulos, et al., 2022; Moratti, et al., 2021).
Regarding pneumodissection, the available literature consists of case series, technical reports, and animal studies (Pearle, et al., 1997; Hüscher & Lirici, 2017; Guilbaud, et al., 2022). These studies describe the technique and report on safety and feasibility.
Data on use injection of specific gels or deployment of small balloons for percutaneous tissue displacement are preclinical, feasibility, or preliminary clinical reports. For example, Johnson et al. (2013) investigated a thermoreversible poloxamer gel for percutaneous hydrodissection, demonstrating feasibility and protective properties in ex vivo models. Giménez et al. (2019) performed a prospective animal study using percutaneous hydrogel injection to simulate hernia repair, showing technical success and safety.
Automatic Continuous Effusion Shunt (ACES)
The Automatic Continuous Effusion Shunt (ACES) device (Pleural Dynamics) uses the motion of normal breathing to automatically and continuously move pleural effusion fluid from the pleural space to the peritoneal space where the pleural fluid is reabsorbed by the body. ACES is a fully implantable treatment. The pump chamber is placed under the skin between the ribs with one catheter in the pleural space and the other in the abdomen for drainage. The ACES System was cleared by the FDA (510(k) No. K231096) for use in adult (>21 years of age) patients with intractable aseptic pleural effusion or chylothorax. A clinical study sponsored by the manufacturer, The ACES Study for Aseptic Pleural Effusions (NCT06210685), is currently ongoing.
Appendix
Staging of Pressure Ulcers
The staging of pressure ulcers is as follows:
| Stages | Staging of Pressure Ulcers |
|---|---|
| Stage I | Non-blanchable erythema of intact skin |
| Stage II | Partial thickness skin loss involving epidermis and/or dermis |
| Stage III | Full thickness skin loss involving damage or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia |
| Stage IV | Full thickness skin loss with extensive destruction, tissue necrosis or damage to muscle, bone, or supporting structures |
References
The above policy is based on the following references:
- Adderley UJ, Holt IG. Topical agents and dressings for fungating wounds. Cochrane Database Syst Rev. 2014;5:CD003948.
- Asimakopoulos AD, Annino F, Pastore AL, et al. Free-hand, transrectal ultrasound-guided hydrodissection of the retroprostatic space during robot-assisted radical prostatectomy: Impact on the learning curve. Urol Oncol. 2022;40(9):408.e1-408.e8.
- Andrew Glennie R, Dea N, Street JT. Dressings and drains in posterior spine surgery and their effect on wound complications. J Clin Neurosci. 2015;22(7):1081-1087.
- Attinger CE, Janis JE, Steinberg J, et al. Clinical approach to wounds: Debridement and wound bed preparation including the use of dressings and wound-healing adjuvants. Plast Reconstr Surg. 2006;117(7 Suppl):72S-109S.
- Bradley M, Cullum N, Nelson EA, et al. Systematic reviews of wound care management: (2). Dressings and topical agents used in the healing of chronic wounds. Health Technol Assess. 1999;3(17 Pt 2):1-35.
- Brem H, Sheehan P, Boulton AJ. Protocol for treatment of diabetic foot ulcers. Am J Surg. 2004;187(5A):1S-10S.
- Briggs M, Nelson EA, Martyn-St James M. Topical agents or dressings for pain in venous leg ulcers. Cochrane Database Syst Rev. 2012;11:CD001177.
- Briggs M, Nelson EA. Topical agents or dressings for pain in venous leg ulcers. Cochrane Database Syst Rev. 2010;(4):CD001177.
- Brolmann FE, Eskes AM, Goslings JC, et al; REMBRANDT study group. Randomized clinical trial of donor-site wound dressings after split-skin grafting. Br J Surg. 2013;100(5):619-627.
- Burrows E. Effectiveness of occlusive dressings versus non-occlusive dressings for reducing infections in surgical wounds. Evidence Centre Evidence Report. Clayton, VIC: Centre for Clinical Effectiveness (CCE); 2000.
- Carville K. Which dressing should I use? It all depends on the 'TIMEING'. Aust Fam Physician. 2006;35(7):486-489.
- Cassino R, Ricci E. Effectiveness of topical application of amino acids to chronic wounds: A prospective observational study. J Wound Care. 2010;19(1):29-34.
- Costa ML, Achten J, Bruce J, et al; UK WOLLF Collaboration. Effect of negative pressure wound therapy vs standard wound management on 12-month disability among adults with severe open fracture of the lower limb: The WOLLF randomized clinical trial. JAMA. 2018;319(22):2280-2288.
- Coulthard P, Esposito M, Worthington HV, et al. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2010;(5):CD004287.
- D'Urso A, Komen N, Lefevre JH. Intraluminal flexible sheath for the protection of low anastomosis after anterior resection: Results from a First-In-Human trial on 15 patients. Surg Endosc. 2020;34(11):5107-5116.
- De Hous N, D'Urso A, Cadière GB, et al. Evaluation of the SafeHeal Colovac+ anastomosis protection device after low anterior resection for rectal cancer: The safe anastomosis feasibility evaluation (SAFE) 2019 trial. Surg Endosc. 2023;37(9):7385-7392.
- De Hous N, Khosrovani C, Lefevre JH, et al. Evaluation of the SafeHeal Colovac+ Anastomosis Protection Device: A preclinical study. Surg Innov. 2022;29(3):390-397.
- Dinah F, Adhikari A. Gauze packing of open surgical wounds: Empirical or evidence-based practice? Ann R Coll Surg Engl. 2006;88(1):33-36.
- Dumville JC, Coulthard P, Worthington HV, et al. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2014;11:CD004287.
- Dumville JC, Deshpande S, O'Meara S, Speak K. Foam dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2011;(9):CD009111.
- Dumville JC, Deshpande S, O'Meara S, Speak K. Hydrocolloid dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2012;(2):CD009099.
- Dumville JC, Deshpande S, O'Meara S, Speak K. Hydrocolloid dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2013;8:CD009099..
- Dumville JC, Gray TA, Walter CJ, et al. Dressings for the prevention of surgical site infection. Cochrane Database Syst Rev. 2016;12:CD003091.
- Dumville JC, O'Meara S, Deshpande S, Speak K. Alginate dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2012;(2):CD009110.
- Dumville JC, O'Meara S, Deshpande S, Speak K. Hydrogel dressings for healing diabetic foot ulcers. Cochrane Database Syst Rev. 2011;(9):CD009101.
- Dumville JC, Walter CJ, Sharp CA, Page T. Dressings for the prevention of surgical site infection. Cochrane Database Syst Rev. 2011;(7):CD003091.
- Dziewulski P, James S, Taylor D, et al. Modern dressings: Healing surgical wounds by secondary intention. Hosp Med. 2003;64(9):543-547.
- Edwards J, Stapley S. Debridement of diabetic foot ulcers. Cochrane Database Syst Rev. 2010;(1):CD003556.
- Fernandez R, Griffiths R. Water for wound cleansing. Cochrane Database Syst Rev. 2012;(2):CD003861.
- Giménez ME, Davrieux CF, Serra E, et al. Application of a novel material in the inguinal region using a totally percutaneous approach in an animal model: A new potential technique? Hernia. 2019;23(6):1175-1185.
- Guilbaud T, Cermolacce A, Berdah S, Birnbaum DJ. New 5-mm laparoscopic pneumodissector device to improve laparoscopic dissection: An experimental study of its safety in a swine model. Surg Endosc. 2022;36(4):2712-2720.
- Hain E, Lefèvre JH, Ricardo A, et al. SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: An international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device. Colorectal Dis. 2024;26(6):1271-1284.
- Hüscher CGS, Lirici MM. Transanal total mesorectal excision: Pneumodissection of retroperitoneal structures eases laparoscopic rectal resection. Dis Colon Rectum. 2017;60(10):1109-1112.
- Johnson A, Sprangers A, Cassidy P, et al. Design and validation of a thermoreversible material for percutaneous tissue hydrodissection. J Biomed Mater Res B Appl Biomater. 2013;101(8):1400-1409.
- Lairet KF, Baer D, Leas ML, et al. Evaluation of an oxygen-diffusion dressing for accelerated healing of donor-site wounds. J Burn Care Res. 2014;35(3):214-218.
- Langenbach MR, Chondros S, Sauerland S. Tamponade dressings may be unnecessary after haemorrhoidectomy: A randomised controlled clinical trial. Int J Colorectal Dis. 2014;29(3):395-400.
- Langenbach MR, Seidel D. Tamponade dressings versus no tamponade after hemorrhoidectomy: Study protocol for a randomized controlled trial. Trials. 2019;20(1):188.
- Lewis R, Whiting P, ter Riet G, et al. A rapid and systematic review of the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention. Health Technol Assess. 2001;5(14):1-131.
- Li HZ, Zhang L, Chen JX, et al. Silver-containing dressing for surgical site infection in clean and clean-contaminated operations: A systematic review and meta-analysis of randomized controlled trials. J Surg Res. 2017;215:98-107.
- Liu C, He J, Li T, Hong D, Su H, Shao H. Evaluation of the efficacy and postoperative outcomes of hydrodissection-assisted microwave ablation for subcapsular hepatocellular carcinoma and colorectal liver metastases. Abdom Radiol (NY). 2021;46(5):2161-2172.
- Lund-Nielsen B, Adamsen L, Gottrup F, et al. Qualitative bacteriology in malignant wounds -- a prospective, randomized, clinical study to compare the effect of honey and silver dressings. Ostomy Wound Manage. 2011;57(7):28-36.
- Marsh N, Webster J, Mihala G, Rickard CM. Devices and dressings to secure peripheral venous catheters to prevent complications. Cochrane Database Syst Rev. 2015;6:CD011070.
- Merle G, Comeau-Gauthier M, Tayari V, et al. Comparison of three devices to measure pressure for acute compartment syndrome. Mil Med. 2020;185(Suppl 1):77-81.
- Montreuil J, Corban J, Reindl R, Harvey EJ, Bernstein M. Novel digital continuous sensor for monitoring of compartment pressure: a case report. OTA Int. 2022;5(3):e208.
- Moratti Gilberto G, Mina Falsarella P, Batalha Megale A, et al. Pressurized hydrodissection for CT-guided percutaneous peritoneal navigation: The hydro jet technique. Eur J Radiol. 2021;145:110042.
- MYO1, Inc. MY01 Announces Presentation of Clinical Trial Data at Clinical Orthopaedic Society Annual Meeting. Press Release. MY01; September 9, 2022.
- National Institute for Clinical Excellence (NICE). Guidance on the use of debriding agents and specialist wound care clinics for difficult to heal surgical wounds. Technology Appraisal Guidance No. 24. London, UK: NICE; April 2001.
- National Institute for Health Research (NIHR). Negative pressure dressings are no better than standard dressings for open fractures. NIHR Signal. London, UK: NIHR; October 9, 2018.
- Nelson EA, Bradley MD. Dressings and topical agents for arterial leg ulcers. Cochrane Database Syst Rev. 2007;(1):CD001836.
- Neo EJR, Shan NT, Tay SS. Hydrodissection for carpal tunnel syndrome: A systematic review. Am J Phys Med Rehabil. 2022;101(6):530-539.
- NHIC Corp. Local Coverage Determination (LCD) for Surgical Dressings (L11471). DME MAC Jurisdiction A. Hingham, MA: NHIC; revised June 1, 2013.
- Noridian Healthcare Solutions, LLC. Surgical dressings. Local Coverage Determination No. L33831. Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Jurisdiction D. Fargo, ND: Noridian; revised October 1, 2015.
- Noridian Healthcare Solutions, LLC. Surgical dressings. Policy Article No. A52491. Fargo, ND: Noridian; effective October 2015.
- O'Meara S, Al-Kurdi D, Ologun Y, Ovington LG. Antibiotics and antiseptics for venous leg ulcers. Cochrane Database Syst Rev. 2010;(1):CD003557.
- O'Meara S, Cullum N, Majid M, Sheldon T. Systematic reviews of wound care management: (3) antimicrobial agents for chronic wounds; (4) diabetic foot ulceration. Health Technol Assess. 2000;4(21):1-237.
- Palfreyman SSJ, Nelson EA, Lochiel R, Michaels JA. Dressings for healing venous leg ulcers. Cochrane Database Syst Rev. 2006;(3):CD001103.
- Pearle MS, Nakada SY, McDougall EM, et al. Laparoscopic pneumodissection: Results in initial 20 patients. J Am Coll Surg. 1997;184(6):579-583.
- Phipps WJ, Long BC, Woods NF, eds. Medical-Surgical Nursing. Concepts and Clinical Practice. 3rd ed. St. Louis, MO: CV Mosby Co.; 1987.
- SafeHeal Inc. Health Professionals [website]. Tampa, FL: SafeHeal: 2025. Available at: https://www.safeheal.com/professionals/. Accessed June 10, 2025.
- SafeHeal Inc. SafeHeal Receives Breakthrough Device designation for Colovac Endoluminal Bypass Sheath. Press release [website]. Tampa, FL: SafeHeal; 2025. Available at: https://www.safeheal.com/safeheal-receives-breakthrough-device-designation-for-colovac-endoluminal-bypass-sheath/. Accessed June 10, 2025.
- Seadler MS, Turner H, Hayssen WG, et al. The effect of both tube diameter and irrigation volume on retained HEMOTHORAX after thoracic irrigation in swine. J Trauma Acute Care Surg. Published online July 25, 2025.
- Shalini R, Sivaranjani M, Balaji CRK, Grahalakshmi A. Continuous positive and negative pressure dressing -- A novel approach in the treatment of auricular seroma. Indian J Otolaryngol Head Neck Surg. 2025;77(1):115-119.
- Singh A, Halder S, Menon GR, et al. Meta-analysis of randomized controlled trials on hydrocolloid occlusive dressing versus conventional gauze dressing in the healing of chronic wounds. Asian J Surg. 2004;27(4):326-332.
- Sinha S, Schreiner AJ, Biernaskie J, et al. Treating pain on skin graft donor sites: Review and clinical recommendations. J Trauma Acute Care Surg. 2017;83(5):954-964.
- Smith F, Dryburgh N, Donaldson J, Mitchell M. Debridement for surgical wounds. Cochrane Database Syst Rev. 2011;(5):CD006214.
- Smith SR, Newton K, Smith JA, et al. Internal dressings for healing perianal abscess cavities. Cochrane Database Syst Rev. 2016;(8):CD011193.
- Srivastava N, Manisha, Ghai A, et al. Comparative efficacy of advanced and traditional wound dressings in post-operative orthopaedic care for hip and knee surgeries: A randomized controlled trial. J Clin Orthop Trauma. 2025;:63:102933.
- Suddith U, Whitford, R. The role of a continuous compartment pressure device in managing acute compartment syndrome in patients requiring mechanical circulatory support [abstract]. ASAIO J. 2024;70(Supp 4):63,
- Swan MC, Oliver DW, Cassell OC, et al. Randomized controlled trial of fibrin sealant to reduce postoperative drainage following elective lymph node dissection. Br J Surg. 2011;98(7):918-924.
- Talbot TR, Stone EC, Irwin K, et al.; Healthcare Infection Control Practices Advisory Committee. 2017 Updated Recommendations on the Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections. Atlanta, GA: Division of Healthcare Quality Promotion, National Center for Zoonotic and Emerging Infectious Diseases, Centers for Disease Control and Prevention; updated July 17, 2017.
- Toon CD, Ramamoorthy R, Davidson BR, Gurusamy KS. Early versus delayed dressing removal after primary closure of clean and clean-contaminated surgical wounds. Cochrane Database Syst Rev. 2013;9:CD010259.
- Totty JP, Bua N, Smith GE, et al. Dialkylcarbamoyl chloride (DACC)-coated dressings in the management and prevention of wound infection: A systematic review. J Wound Care. 2017;26(3):107-114.
- Tricenturion LLC. Surgical dressings. Local Coverage Determination No. L11471. Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Jurisdiction A/B. Columbia, SC: Tricenturion; revised March 1, 2008.
- U.S. Department of Health and Human Services, Health Care Financing Administration (HCFA). Surgical dressings, and splints, casts, and other devices used for reductions of fracture. Medicare Carriers Manual §2079. Baltimore, MD: HCFA; 2000.
- Ullman AJ, Cooke ML, Mitchell M, et al. Dressings and securement devices for central venous catheters (CVC). Cochrane Database Syst Rev. 2015;9:CD010367.
- Uribe J, Parrish RC, Pyarali F, Kheir F. Thoracic irrigation using CLR Irrigator for complicated pleural infection [abstract]. Am J Respir Crit Care Med. 2025;211:A1139.
- Valentine R, Wormald PJ. Nasal dressings after endoscopic sinus surgery: What and why? Curr Opin Otolaryngol Head Neck Surg. 2010;18(1):44-48.
- Vermeulen H, Ubbink D, Goossens A, et al. Dressings and topical agents for surgical wounds healing by secondary intention. Cochrane Database Syst Rev. 2004;(1):CD003554.
- Vermeulen H, Ubbink D, Goossens A, et al. Systematic review of dressings and topical agents for surgical wounds healing by secondary intention. Br J Surg. 2005;92(6):665-672.
- Vermeulen H, van Hattem JM, Storm-Versloot MN, Ubbink DT. Topical silver for treating infected wounds. Cochrane Database Syst Rev. 2007;(1):CD005486.
- Walter CJ, Dumville JC, Sharp CA, Page T. Systematic review and meta-analysis of wound dressings in the prevention of surgical-site infections in surgical wounds healing by primary intention. Br J Surg. 2012;99(9):1185-1194.
- Wang JC, Hsu PC, Wang KA, Chang KV. Ultrasound-guided triamcinolone acetonide hydrodissection for carpal tunnel syndrome: A randomized controlled trial. Front Med (Lausanne). 2021;8:742724.
- Wasiak J, Cleland H, Campbell F. Dressings for superficial and partial thickness burns. Cochrane Database Syst Rev. 2008;(4):CD002106.
- Watret L, White R. Surgical wound management: The role of dressings. Nurs Stand. 2001;15(44):59-62, 64, 66.
- Wei L, Li Y, Li X, et al. Chlorhexidine-impregnated dressing for the prophylaxis of central venous catheter-related complications: A systematic review and meta-analysis. BMC Infect Dis. 2019;19(1):429.
- Wheat JC, Wolf JS Jr. Advances in bioadhesives, tissue sealants, and hemostatic agents. Urol Clin North Am. 2009;36(2):265-275.
