1. Aetna considers the following products for wound care medically necessary according to the criteria indicated below:

   1. Apligraf (graftskin)

      Aetna considers a culture-derived human skin equivalent (HSE) called Apligraf (graftskin) medically necessary for any of the following indications:

      1. In conjunction with standard therapy to promote effective wound healing of chronic, non-infected, partial and full-thickness venous stasis ulcers that have failed conservative measures of greater than one-month duration using regular dressing changes and standard therapeutic compression; or

      2. For use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three-weeks duration that have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.

      Aetna considers Apligraft experimental and investigational for non-covered indications.

   2. Dermagraft

      Aetna considers Dermagraft human fibroblast-derived dermal substitute medically necessary for use (i) in the treatment of full-thickness diabetic foot ulcers greater than six-week duration that extend through the dermis, but without tendon, muscle, joint capsule or bone exposure, and (ii) in the treatment of wounds related to dystrophic epidermolysis bullosa.  Note: Consistent with the FDA-approved labeling of Dermagraft, the product should be used in conjunction with standard wound care regimens.  In addition, the product is not considered medically necessary in persons with an inadequate blood supply to the involved foot.

      Aetna considers Dermagraft experimental and investigational for non-covered indications.

      Dermagraft is contraindicated and has no proven value in infected ulcers and ulcers with sinus tracts.

   3. Systemic Hyperbaric Oxygen Therapy (HBOT)

      Aetna considers systemic hyperbaric oxygen therapy (HBOT) medically necessary as an adjunctive method for treating non-healing, infected, deep lower extremity wounds in members with diabetes. See CPB 172 - Hyperbaric Oxygen Therapy (HBOT).

   4. TransCyte

      Aetna considers TransCyte (allogeneic human dermal fibroblasts), a biosynthetic dressing, medically necessary for the temporary wound covering for surgically excised full-thickness and deep partial-thickness thermal burn wounds in persons who require such a covering before autograft placement; and for the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting. 

      Aetna considers TransCyte experimental and investigational for non-covered indications.

   5. Orcel

      Aetna considers Orcel (bilayered cellular matrix) medically necessary for healing donor site wounds in burn victims, and for use in persons with dystrophic epidermolysis bullosa undergoing hand reconstruction surgery to close and heal wounds created by the surgery, including those at donor sites. 

      Aetna considers Orcel experimental and investigational for non-covered indications.

   6. Biobrane Biosynthetic Dressing

      Aetna considers Biobrane biosynthetic dressing medically necessary for temporary covering of a superficial partial-thickness burn wound.

      Aetna considers Biobrane biosynthetic dressing experimental and investigational for all other indications.

   7. Integra Dermal Regeneration Template and Integra Bilayer Wound Matrix

      Aetna considers Integra Dermal Regeneration Template and Integra Bilayer Wound Matrix (collagen-glycosaminoglycan copolymers) medically necessary for the treatment of individuals with severe burns where there is a limited amount of their own skin to use for autografts or they are too ill to have more wound sites created.

      Aetna considers Integra Dermal Regeneration Template and Integra Bilayer Wound Matrix experimental and investigational for all other indications.

   8. Alloderm

      Aetna considers Alloderm acellular dermal tissue matrix medically necessary for breast reconstructive surgery. Use of Alloderm is considered experimental and investigational for all other indications.

2. Aetna considers any of the following treatments for wound care experimental and investigational because there is inadequate evidence in the peer reviewed medical literature to support their clinical effectiveness:

   1. Autologous Blood-Derived Products: Autologous Platelet-Rich Plasma, Autologous Platelet Gel, and Autologous Platelet-Derived Growth Factors (e.g., Procuren)

      Aetna considers autologous blood-derived products: autologous platelet-rich plasma, autologous platelet gel, and autologous platelet-derived growth factors (e.g., Procuren) experimental and investigational for wound healing because there is insufficient evidence to support their use.  

   2. Silver coated wound dressings

      Aetna considers silver coated wound dressings (e.g., Acticoat, Actisorb) experimental and investigational for wound healing or other indications because there is insufficient evidence to support its use.

   3. Radiofrequency Stimulation

      Aetna considers radiofrequency stimulation devices (e.g., Provant Wound Closure System, MicroVas Vascular Treatment System) experimental and investigational for wound healing because there is insufficient evidence to support their effectiveness.

   4. Graftjacket Regenerative Tissue Matrix and Graftjacket Express Injectable Allograft

      Aetna considers Graftjacket Regenerative Tissue Matrix and Graftjacket Express Injectable Allograft experimental and investigational for wound healing or other indications because there is insufficient scientific evidence in the peer-reviewed published medical literature to support its effectiveness.

   5. PriMatrix Acellular Dermal Tissue Matrix

      Aetna considers PriMatrix acellular dermal tissue matrix experimental and investigational for wound healing or other indications because there is insufficient scientific evidence to support its effectiveness.

   6. Oasis Wound Dressing and Oasis Burn Matrix

      Aetna considers Oasis Wound Dressing and Oasis Burn Matrix experimental and investigational for wound healing or other indications because there is insufficient scientific evidence to support their effectiveness.

   7. E-Z Derm

      Aetna considers E-Z Derm experimental and investigational for wound healing or other indications because there is insufficient scientific evidence to support its effectiveness.

   8. TissueMend®

      Aetna considers TissueMend experimental and investigational for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, Achilles, biceps quadriceps, or other indications because there is insufficient scientific evidence to support its effectiveness.

   9. Veritas® Collagen Matrix

      Aetna considers Veritas Collagen Matrix experimental and investigational for use as an implant in the surgical repair of soft tissue deficiencies or for any other indication because there is insufficient scientific evidence to support its effectiveness.

   10. NeuroMatrix^TM Collagen Nerve Cuff

       Aetna considers NeuroMatrix Collagen Nerve Cuff experimental and investigational for peripheral nerve repair or for any other indication because there is insufficient scientific evidence to support its effectiveness.

       Also see CPB 416 - Nerve Graft During Radical Retropubic Prostatectomy.

   11. TenoGlide^TM Tendon Protector Sheet

       Aetna considers TenoGlide tendon protector sheet (Tendon Wrap^TM tendon protector) experimental and investigational for the management and protection of tendon injuries or for any other indications because there is insufficient scientific evidence to support its effectiveness.

   12. Integra™ Matrix Wound Dressing and Integra Flowable Wound Matrix

       Aetna considers Integra Matrix and Integra Flowable Wound Matrix experimental and investigational for the management of wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, skin tears) and draining wounds or for any other indications because there is insufficient scientific evidence to support its effectiveness.

   13. SurgiMend®

       Aetna considers SurgiMend experimental and investigational for plastic and reconstructive surgery, muscle flap reinforcement, hernia repair, reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons, or for any other indications because there is insufficient scientific evidence to support its effectiveness.

   14. Cymetra Injectable Allograft

       Aetna considers Cymetra Injectable Allograft experimental and investigational for wound healing and for indications other than unilateral vocal cord paralysis (see CPB 253 - Injections for Vocal Cord Paralysis ).

   15. Gammagraft Skin Substitute

       Aetna considers Gammagraft Skin Substitute experimental and investigational for wound healing and other indications.

   For Aetna’s policy on systemic and topical hyperbaric oxygen, see CPB 172 - Hyperbaric Oxygen Therapy (HBOT).

   Also see CPB 334 - Negative Pressure Wound Therapy.

Apligraft:

In recent years, skin grafting has evolved from the initial autograft and allograft preparations to biosynthetic and tissue-engineered human skin equivalents (HSE).  Apligraf (graftskin) is a living, bilayered skin construct.  Like human skin, Apligraf has two primary layers, including an outer, epidermal layer made of living human keratinocytes, the most common cell type of the human epidermis.  The dermal layer of Apligraf consists of living human fibroblasts, the most common cell type in the human dermis.

Apligraf has been approved by the U.S. Food and Drug Administration (FDA) in 1998 for treatment of venous leg ulcers and in 2001 for treatment of diabetic ulcers.  Venous ulceration, a relatively common manifestation of venous hypertension, is often refractory to conservative treatment and difficult to treat. HSE appeared to promote wound healing in three ways: (1) apparent graft "take"; (2) temporary wound closure (persistence of HSE with subsequent wound re-epithelialization from wound margins); and (3) stimulation of host healing without temporary persistence by acting as a biologic dressing.

Apligraf was shown in clinical trials to heal even longstanding (greater than one year's duration) venous leg ulcers more effectively and faster than compression therapy alone.  The results of controlled, multicenter studies indicate that human skin equivalent interacts with the patient's own cells, responds to individual wound characteristics, and promotes healing.  Further studies are underway to investigate its use for the treatment of pressure sores, dermatological surgery wounds and burns.  At this time, there is insufficient information to extend coverage for the use of Apligraf in the treatment of these conditions.

Dermagraft:

Another product approved by the FDA for repair of diabetic foot ulcers is Advanced Tissue Science's (La Jolla, CA) Dermagraft, composed of cryopreserved human-derived fibroblasts and collagen applied to a bioabsorbable mesh (similar to the material used in strong bioabsorbable sutures).  During the Dermagraft manufacturing process, the human fibroblasts are seeded onto a bioabsorbable polyglactin mesh scaffold.  The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors and cytokines, to create a three-dimensional human dermal substitute containing metabolically active, living cells.

In support of FDA approval, a 12-week multicenter clinical study was performed involving 314 patients with chronic diabetic ulcers who were randomized to Dermagraft or control.  Patients in the Dermagraft group received up to 8 applications of Dermagraft over the course of the 12-week study.  All patients received pressure-reducing footwear and were encouraged to stay off their study foot as much as possible.  By week 12, the median percent wound closure for the Dermagraft group was 91% compared to 78% for the control group.  The study also showed that ulcers treated with Dermagraft closed significantly faster than ulcers treated with conventional therapy.  Patients treated with Dermagraft were 1.7 times more likely to close than control patients at any given time during the study.  No serious adverse events were attributed to Dermagraft.  There was a lower rate of infection, cellulitis, and osteomyelitis in the Dermagraft treated group.  Of the patients enrolled, 10.4% of the Dermagraft patients developed an infection while 17.9% of the Control patients developed ulcer infection.  Overall, 19% of the Dermagraft group developed infection, cellulitis, or osteomyelitis. In the control group, 32.5% patients developed the same adverse events.  Dermagraft has also been approved by the FDA for use in the treatment of wounds related to dystrophic epidermolysis bullosa.

TransCyte:

TransCyte (Advanced Tissue Sciences Inc. La Jolla, CA), a bioactive skin substitute, was approved by the FDA in 1997.  It consists of human dermal fibroblasts grown on nylon mesh, combined with a synthetic epidermal layer.  TransCyte can be used as a temporary covering over full thickness and some partial-thickness burns until autografting is possible.  It can also be used as a temporary covering for some burn wounds that heal without autografting.  TransCyte is packaged and shipped in a cryopreserved state to burn treatment centers.  The surgeon then thaws the product and stretches it over a burn site.  In about 7 to 14 days, the TransCyte starts peeling off, and the surgeon trims it away as it peels.

Orcel:

Orcel (Ortec International, Inc., New York, NY) was approved by the FDA under its humanitarian device exemption (HDE) in 2001 for healing donor site wounds in burn victims, and for use in patients with recessive dystrophic epidermolysis bullosa (RDEB) undergoing hand reconstruction surgery to close and heal wounds created by the surgery, including those at donor sites.  Orcel is an absorbable bilayered cellular matrix, made of bovine collagen, in which human dermal cells have been cultured.  When this dressing is applied to the open wound created where the patient's healthy skin was removed, the patient's own skin cells migrate into the dressing and take hold, along with the cultured cells, as healing commences.  The dressing is gradually absorbed during the healing process.  OrCel is being investigated for use in several additional indications including venous ulcers, diabetic skin ulcers, and use as primary therapy for burn wounds.

Autologous Blood Derived Products: Autologous Platelet-Rich Plasma, Autologous Platelet Gel, and Autologous Platelet-Derived Growth Factors (e.g., Procuren):

Procuren is a platelet-derived growth factor suggested for use in the management of chronic non-healing wounds.  The Agency for Health Care Policy and Research's Clinical Practice Guideline Treatment of Pressure Ulcers concluded that the effectiveness of growth factors for this indication has not been sufficiently established to warrant recommendation for use.  In 1992, the Centers for Medicare and Medicaid Services (CMS) issued a national non-coverage determination for platelet-derived wound healing formulas intended to treat patients with chronic, non-healing wounds.  This decision was based on a lack of sufficient published data to determine safety and efficacy, and a Public Health Service technology assessment.  A CMS Decision Memorandum (2003) concluded that there is insufficient evidence of the effectiveness of autologous platelet rich plasma (PRP) or autologous platelet-derived growth factor (PDGF) in improving healing in chronic non-healing cutaneous wounds.  In a second reconsideration, CMS concluded there is insufficient evidence of effectiveness of autologous PRP for the treatment of chronic non-healing cutaneous wounds or for acute surgical wounds when the autologous PRP is applied directly to the closed incision or dehiscent wounds (CMS, 2007).

Silver Coated Wound Dressings (Acticoat, Actisorb):

Silver coated wound dressings produce sustained release of ionic silver to decrease the incidence of infection. As the dressing material accumulates fluid, silver ions are released from the dressing into the wound environment. Silver-coating technology was developed to prevent wound adhesion, limit nosocomial infection, control bacterial growth, and facilitate burn wound care through a silver-coated dressing material. Silver coated wound dressings such as Acticoat and Actisorb offer new forms of dressing for burn wounds, but require further investigation. Well controlled clinical trials are needed comparing clinical outcomes of silver coated wound dressings with standard wound dressings in patients in various phases of burn wound care. An evidence review prepared for the Cochrane Collaboration (Bergin, et al., 2006) concluded: "Despite the widespread use of dressings and topical agents containing silver for the treatment of diabetic foot ulcers, no randomised trials or controlled clinical trials exist that evaluate their clinical effectiveness. Trials are needed to determine clinical and cost-effectiveness and long term outcomes including adverse events."

The Provant Wound Closure System:

The Provant Wound Closure System (Regenesis Biomedical Inc., Scottsdale, AZ) uses a low-level radiofrequency signal that proponents state accelerates healing of chronic wounds by stimulating the production of endogenous growth factors and the proliferation of fibroblasts and epithelial cells, in a process the manufacturer has labeled "Cell Proliferation Induction" or CPI.  The Provant Wound Closure System (Regenesis was cleared by the FDA as a wound healing device based on a 510(k) premarket notification.  Treatment with the Provant System is usually administered for 30 minutes right through dressing twice-daily.  However, there is insufficient clinical evidence to support its effectiveness.  Available evidence on CPI has focused mainly on the effects of low-level radiofrequency signals on growth factors and cell proliferation in vitro.  Peer-reviewed literature is limited to a small short-term randomized controlled pilot study which found that the Provant system accelerated closure of pressure wounds (Ritz et al., 2002).  This finding needs to be verified by larger multicenter studies.  Furthermore, studies would need to assess if CPI adds to the effectiveness of standard methods of chronic wound management.  

MicroVas:

MicroVas (MicroVas Technologies, Inc., Tulsa OK) is a radiofrequency stimulation device used to increase circulation to an extremity or body part in order to speed wound healing.  According to the manufacturer, MicroVas is indicated for the treatment of stage III and IV pressure ulcers.  The manufacturer states that the MicroVas is also indicated for the treatment of chronic and non-healing diabetic and venous ulcers, treatment of ischemic rest pain, muscle disuse atrophy, diabetic neuropathy, and paresthesia relating to neuropathy.  However, there is a lack of scientific evidence to support its effectiveness for these indications.

A recently published meta-analysis concluded that there is no reliable evidence of benefit of electromagnetic therapy generally in healing of pressure sores (Flemming, et al., 2002a) or venous leg ulcers (Flemming, et al., 2002b).  Additionally, a recent systemic review of the literature on treatment of pressure sores concluded that the effectiveness of electrotherapy on pressure sores is unknown (Cullum, et al., 2002). 

Graftjacket Tissue Matrix:

Graftjacket tissue matrix (Wright Medical Technology, Inc, Arlington, TN) is an acellular regenerative tissue matrix that has been developed to aid in wound repair.  In a pilot, prospective, randomized study (n = 40), Brigido, et al. (2004) ascertained the effectiveness of this tissue product in wound repairing of diabetic foot ulcers compared with conventional treatment.  Only a single administration of the tissue matrix was required.  After 1 month of treatment, preliminary results showed that this novel tissue matrix promoted faster healing at a statistically significant rate over conventional treatment.  Results of this study are promising, but they need to be verified by further investigation with larger sample sizes and longer follow-ups.

Graftjacket Xpress Flowable Soft-Tissue Scaffold is a micronized (finely ground) decellularized soft tissue scaffold indicated for the repair or replacement of damaged or inadequate integumental tissue, specifically deep, dermal wounds that exhibit tunneling, and extension from the wound base that may extend deep into the tendon and bone (CMS, 2006).  Graftjacket Xpress is a soft tissue graft (reconstituted as a “gel”), which is comprised solely of human dermal tissue, including its native protein and collagen structure and essential biochemical composition. The re-hydrated skin substitute scaffold is placed into the tunnels or tracts, and is intended to produce the same or superior clinical outcomes with a minimally invasive procedure. There is a lack of peer-reviewed published medical literature on the effectiveness and safety of the Graftjacket Xpress.

PriMatrix Acellular Dermal Tissue Matrix:

PriMatrix acellular dermal tissue matrix, formerly known as DressSkin (TEI Biosciences Inc., Boston, MA) was cleared by the FDA via the 510(k) process in September 2003.  It is an acellular collagen dermal tissue matrix derived from fetal bovine skin.  PriMatrix is indicated for the management of wounds including second degree burns, draining, surgical, and trauma wounds, as well as pressure, diabetic, and venous ulcers.  However, there is insufficient scientific evidence regarding the effectiveness of PriMatrix acellular dermal tissue matrix for wound healing.

Oasis Wound Dressing and Oasis Burn Matrix:

Oasis wound dressing (Cook Biotech Inc., West Lafayette, IN), a tissue-engineered collagen matrix derived from the porcine small intestinal submucosa (SIS), was cleared by the FDA in 2000 for the management of full-thickness skin injuries including trauma wounds such as 2nd-degree burns, abrasions, lacerations and skin tears; pressure, venous, diabetic, and chronic vascular ulcers; surgical wounds such as autograft donor sites; tunneled/undermined wounds; as well as draining wounds.  Oasis wound dressing is provided in single sheets (7 cm wide by 10 or 20 cm long) intended for one-time use only.

In a prospective, randomized, controlled multi-center study (n = 120), Mostow and colleagues (2005) examined the effectiveness of Oasis in the treatment of chronic leg ulcers.  Patients were randomly assigned to receive either weekly topical treatment of SIS combined with compression therapy (n = 62) or compression therapy alone (n = 58).  Ulcer size was determined at enrollment and weekly throughout the treatment.  Healing was assessed weekly for up to 12 weeks.  Recurrence after 6 months was recorded.  The primary outcome measure was the proportion of ulcers healed in each group at 12 weeks.  After 12 weeks of treatment, 55% of the wounds in the Oasis group were healed, as compared with 34% in the standard-care group (p = 0.0196).  None of the healed Oasis-treated subjects who were seen at the 6-month follow-up experienced ulcer recurrence.  These investigators concluded that Oasis, as an adjunct therapy, significantly improved healing of chronic leg ulcers over compression therapy alone.  Moreover, the authors noted that a definitive link between the composition of Oasis and its positive effects on chronic wounds has not been established.  Also, the limited number of wounds examined at the 6-month follow-up suggested that more research especially longer follow-up is needed to ascertain recurrence after treatment with Oasis.

In another randomized, prospective, controlled multi-center study (n = 73), Niezgoda, et al. (2005) compared healing rates at 12 weeks for patients with full-thickness diabetic foot ulcers treated with Oasis versus Regranex gel.  Patients with at least 1 diabetic foot ulcer were entered into the trial and completed the protocol.  They were randomized to receive either Oasis (n = 37) or Regranex gel (n = 36) and a secondary dressing.  Wounds were cleansed and debrided, if needed, at a weekly clinic visit.  Dressings were changed as needed.  The maximum treatment period for each patient was 12 weeks.  After 12 weeks of treatment, 18 (49%) Oasis-treated subjects had complete wound closure compared with 10 (28%) Regranex-treated patients.  These researchers concluded that although the sample size was not large enough to demonstrate that the incidence of healing in the Oasis group was statistically superior (p = 0.055), the study results showed that treatment with Oasis is as effective as Regranex in healing full-thickness diabetic foot ulcers by 12 weeks.  One of the drawbacks of this study was that the findings did not reach statistical significance, namely, the overall healing rates between groups were similar.  In addition, there were more cases of infection in the Oasis-treated group than the Regranex-treated group.  Furthermore, the 6-month follow-up evaluation did not allow for adequate evaluation of long-term effectiveness.

Oasis Burn Matrix (Cook Biotech Inc., West Lafayette, IN) is a extracellular matrix created from the submucosal layer of porcine small intestine. The submucosa is extracted in a manner that removes all cells but leaves the submucosa matrix intact. This matrix is intended to provide an acellular scaffold that accommodates remodeling of host tissue. The Oasis Burn Matrix has increased thickness allowing application for an extended period of time. There is a lack of evidence in the peer-reviewed published medical literature on the effectiveness of the Oasis Burn Matrix.

BioBrane:

Biobrane (Mylan Laboratories, Inc., Canonsburg, PA) is a biosynthetic wound dressing constructed of a silicon film with a nylon fabric partially imbedded into the film.  The fabric presents to the wound bed a complex 3-dimensional structure of tri-filament thread to which collagen has been chemically bound.  Blood/sera clot in the nylon matrix, thus, firmly adhering the dressing to the wound until epithelialization occurs. 

Phillips, et al. (1989) reviewed 851 applications of Biobrane on partial skin thickness burn wounds awaiting epithelialization.  After the patients had been evaluated and resuscitated as needed, the burn wounds were cleansed and debrided.  Those evaluated as shallow were treated with Biobrane application.  Joint surfaces were splinted for immobilization.  The wound was inspected at 24 and 48 hours and if any fluid had accumulated it was aspirated and the wound was redressed.  When the Biobrane was adherent, the wound was covered with a light dressing and joint immobilization was discontinued.  Treatment with Biobrane dressing provided certain advantages over other topical wound care.  As the dressing changes were performed less frequently outpatient care was possible, with a resultant decrease in both the length of hospital stay and the ultimate cost of burn care.  Wound desiccation is prevented and pain is decreased.  Accurate diagnosis of wound depth is crucial if Biobrane is to be used.  Very deep wounds will not allow Biobrane adherence, neither will it occur if the wound has a high bacterial count.  If joint surfaces are not splinted, the Biobrane will shear and not adhere to the wound.  Convex and concave surfaces can be treated with Biobrane, which may need to be meshed.

Bishop (1995) noted that Biobrane offers a number of advantages as a wound dressing for children.  It does not require the use of surgical instruments, noisy distractions, painful manipulation of the wound, or regimented daily dressing changes.  Biobrane does offer the pediatric patient with burns immediate comfort and protection, and enhances patient compliance and parental satisfaction.  This is corroborated by the findings of Cassidy, et al. (2005).  These researchers compared the effectiveness of Biobrane and Duoderm for the treatment of small intermediate thickness burns in children in a prospective, randomized fashion to determine their relative impact on wound healing, pain scores, and cost.  Patients under 18 years of age with intermediate thickness burns on a surface area less than 10% were enrolled and treated with one of the two dressing systems.  Data collected included mechanism of injury, time to complete healing, pain scores, and institutional cost of materials until healing was complete.  No significant difference in time to healing or pain scores was detected between the two groups.  The cost of each treatment was statistically more expensive in the Biobrane group.  The results of this study showed that Duoderm and Biobrane provide equally effective treatment of partial thickness burns among in the pediatric population. 

Barret, et al. (2000) stated that partial-thickness burns in children have been treated for many years by daily, painful tubbing, washing, and cleansing of the burn wound, followed by topical application of anti-microbial creams.  Pain and impaired wound healing are the main problems.  These investigators hypothesized that the treatment of 2nd-degree burns with Biobrane is superior to topical treatment.  A total of 20 pediatric patients were prospectively randomized into 2 groups to compare the effectiveness of Biobrane versus 1% silver sulfadiazine.  The rest of the routine clinical protocols were followed in both groups.  Demographic data, wound healing time, length of hospital stay, pain assessments and pain medication requirements, and infection were analyzed and compared.  Main outcome measures included pain, pain medication requirements, wound healing time, length of hospital stay, and infection.  The application of Biobrane to partial-thickness burns proved to be superior to the topical treatment.  Patients included in the biosynthetic temporary cover group presented with less pain and required less pain medication.  Length of hospital stay and wound healing time were also significantly shorter in the Biobrane group.  None of the patients in either group presented with wound infection or needed skin autografting.  The authors concluded that the treatment of partial-thickness burns with Biobrane is superior to topical therapy with 1% silver sulfadiazine.  Pain, pain medication requirements, wound healing time, and length of hospital stay are significantly reduced.  Furthermore, in a review on tissue-engineered temporary wound coverings, Ehrenreich and Ruszczak (2006) stated that “[b]oth Biobrane and TransCyte have a strong body of evidence supporting their use in acute wounds.  The most important clinical advantages of both products are prevention of wound desiccation, reduction in pain, reduced dressing changes, and in most reported studies, an acceleration in healing….TransCyte may be justified in full thickness and deep partial thickness injuries, whereas Biobrane is more appropriate for more superficial wounds”.

AlloDerm:

AlloDerm (Life Cell Corp., The Woodlands, TX), an acellular dermal matrix processed from human allograft skin, has been used in the treatment of burn injury.  However, there is currently limited evidence to support the use of AlloDerm for wound healing.

Lattari, et al. (1997) described the use of AlloDerm dermal grafts on 3 patients with full-thickness burns of the distal extremities.  Grafts were applied to the hand in 2 cases and the dorsum of the foot in the 3rd case.  Range of motion, grip strength, fine motor coordination, and functional performance were quantitatively evaluated.  As shown by these patients, cosmetic and functional results were considered good to excellent after the use of AlloDerm grafts with thin autografts.

Tsai, et al. (1999) presented 12 cases of clinical application of a composite grafting technique in which AlloDerm provided source of dermis, and an ultra-thin autograft (0.004  to 0.006 inch in thickness) provided epidermis.  In these patients, the composite grafts were applied to full-thickness burn wounds over various articular skin surfaces.  The average skin graft take rate was 91.5%. These ultra-thin autografts allow the donor sites to heal faster.  The mean time of donor site re-epithelization was 6 days.  All patients had a nearly normal range of joint motion (average 95% of normal) after 1 year's follow up.  Wound assessment over time has shown supple skin that has been resistant to trauma and infection.  The cosmetic results were judged to be fair to good by surgeons and patients after 1 year's follow up.

Gore (2005) stated that because skin thins with advancing age, traditional thickness skin grafts cannot always be obtained in very elderly burn patients without creating a new full-thickness wound at the skin graft donor site.  In an attempt to circumvent this problem, AlloDerm and thin autograft (depth 0.005 inches) were used in skin grafting 10 elderly burn patients (age of 78 years +/- 2, TBSA burn 17% +/- 2; mean +/- SEM) over a 1-year period.  The outcome of patients receiving AlloDerm was compared retrospectively to a similar group of 18 elderly patients admitted over the prior year, 8 of whom underwent operative wound excision and autografting (depth 0.014 inches) without AlloDerm.  Length of hospital stay was significantly reduced in patients treated with AlloDerm compared to the total group of elderly in whom selective use of operative debridement and skin grafting was used.  Functional outcome was improved in those patients who underwent skin grafting regardless of operative technique.  Donor site healing time was significantly reduced with AlloDerm (12 days +/- 1 versus 18 days +/- 2), while graft take was similar to conventional autografting.  Unfortunately, 3-month mortality remained poor regardless of operative skin grafting or technique used.  The authors concluded that these findings suggested that use of AlloDerm may allow more elderly burn patients to undergo operative wound closure, thus improving functional outcome and reducing hospitalization.  Unfortunately, long-term survival for very elderly burn patients remains poor.

A number of papers have examined the use of AlloDerm as a tissue graft for contaminated abdominal wall defects and hernia repair. Wound infection and infection of the mesh can be grave complications of hernia repair, often necessitating removal of the mesh and application of a tissue graft. In breast reconstruction, AlloDerm has been used in conjunction with a subpectoral (major) placement of breast implants to achieve more complete implant coverage without the use of other muscles. Although these indications are promising, evidence is limited to small retrospective case series with limited followup.

Ventral hernia repair in potentially contaminated or potentially infected fields limit the use of synthetic mesh products. In this scenario, biosynthetic mesh products that are absorbed and/or replaced with the body's own tissue are intended to reduce the incidence of post-operative chronic wound complications. Rapid revascularization, repopulation, and remodeling of the matrix occur on contact with the patient's own tissue. Only limited, and mostly preliminary data, is available on the use of these types of mesh and concerning the potential complications associated with the use of these types of meshes.

In one of the few published comparative studies of AlloDerm in hernia repair, Gupta, et al. (2006) compared the efficacy and the complications associated with the use AlloDerm and Surgisis bioactive mesh (Cook Surgical, Bloomington, IN), a product obtained by the processing of porcine small intestine submucosa, for ventral herniorrhaphy. The investigators reported on the outcomes of 74 patients who underwent ventral hernia repair using these products between June 2002 and March 2005. The first 41 procedures were performed using Surgisis bioactive mesh, and the remaining 33 patients had ventral hernia repair with AlloDerm. The investigators reported that the use of the AlloDerm mesh resulted in eight hernia recurrences. Fifteen of the 33 patients treated with AlloDerm developed a diastasis or bulging at the repair site. Seroma formation was only a problem in two patients. The investigators reported that the Surgisis bioactive mesh resulted in significant seroma formation in over one quarter of patients. Explanted material revealed separated layers of unincorporated middle layers of the Surgisis mesh. The investigators reported that three of the patients had the mesh placed in a contaminated field with no resultant sequela, and there were no hernia recurrences. Patients also had a significant degree of discomfort and pain during the immediate post-operative period. The investigators concluded that post-operative diastasis and hernia recurrence were a major problem with the AlloDerm mesh. On the other hand, seroma formation was a major problem with the Surgisis mesh repair, as was the post-operative pain. The investigators recommended further design improvements in both forms of these new mesh products.

In another comparative study, Espinosa-de-los-Monteros, et al. (2007) retrospectively reviewed 39 abdominal wall reconstructions with AlloDerm in 37 patients and compared them with 39 randomly selected abdominal wall reconstructions without AlloDerm. The investigators reported a significant decrease in recurrence rates when AlloDerm was added as an overlay to primary closure plus rectus muscle advancement and imbrication in patients with medium-sized hernias. On the other hand, no differences were observed when adding AlloDerm as an overlay to patients with large-size hernias treated with underlay mesh. 

Jin, et al. (2007) compared two techniques of fascial bridging versus fascial reinforcement repair with regard to their longterm recurrence rates using Alloderm in patients with abdominal wall defects, and concluded that, because of high recurrence rates with fascial bridging, Alloderm should be used only as a reinforcement after primary fascial reappoximation. The investigators retrospectively studied the outcomes of 37 patients with abdominal defects repaired with Alloderm. Eleven patients underwent bridged fascial repair, and 26 patients had reinforced fascial repair. Mean followup was 21.4 months (range 15 to 36 months). In the bridged group, 1 patient died on postoperative day 20. Of the remaining 10 patients, 8 patients (80%) developed recurrences. Seven patients required reoperation, but one patient refused repair. In the reinforced group, four patients were lost to followup and two patients died. Four of the remaining 20 patients (20%) developed recurrences that required repair; this was
significantly different from the recurrence rate in the bridged group (p=0.009).

Bluebond-Lagner, et al. (2008) reported on recurrent laxity requiring secondary intervention in a series of patients who were repaired with interpositional Alloderm. The investigators reviewed all patients who underwent repair of massive ventral hernias and identified 7 patients who presented with abdominal wall laxity following component separation with interpositional Alloderm alone. The investigators reported that all patients developed laxity within 12 months and required a secondary procedure. At the time of re-exploration, severe attenuation in the Alloderm was noted. The segment was excised, the edges closed primarily, and prolene mesh was placed as an onlay.

Vetrees, et al. (2008) reported on a retrospective review of outcomes of surgical repair of 83 patients with open abdomen that were treated at Walter Reed Army Medical Center. Surgical management included early definitive abdominal closure (EDAC) (serial abdominal closure with prosthetic Gore-Tex Dualmesh and final closure supplemented with polypropylene mesh or Alloderm in 56 patients, primary fascial closure in 15 patients, planned ventral hernia (PVH) in 9 patients, and vacuum-assisted closure with Alloderm in 3 patients).  Complications included removal of infected prosthetic mesh in 4 EDAC closure patients; the investigators noted that mesh-related complications had decreased over time. The investigators reported that rates of infection, abdominal wall hematoma, deep venous thrombosis, and pulmonary embolism did not differ between groups. In the EDAC group, infections complicated final polypropylene mesh closure in 3 of 28 patients closed with prosthetic mesh; one of 14 patients closed with biologic mesh (Alloderm) noted increased laxity at the repair site. Of 56 patients treated with EDAC, 2 patients had recurrent ventral hernia. Of the three patients closed with Alloderm and vacuum assisted closure, one patient had recurrent ventral hernia. The investigators reported that no final Alloderm closures required removal after placement, but "longterm results have been disappointing ... The excessive cost of biologic material requires better results than those documented in previous studies." Limitations of this study include its lack of randomization, variation in the described closure methods, its retrospective nature, and limitations of some data points. The investigators concluded that "polypropylene mesh final EDAC closure risks infection and subsequent fistula formation, and long-term follow-up are needed. Use of biologic mesh as either final EDAC closure or with vacuum-assisted closure also requires long-term follow-up to justify its increased cost and increased risk of abdominal wall laxity."

Available published evidence regarding the use of Alloderm in breast reconstructive surgery consists primarily of several small case series (e.g., Salzberg, 2006; Breuing & Colwell, 2007; Zienowicz & Karacaoglu, 2007; Garramone & Lam, 2007; Spear, et al., 2008). There are no comparative studies to determine whether the use of Alloderm improves aesthetic outcomes. In addition, the duration of follow-up in published studies is limited so the impact on longer-term complications such as severe contractures cannot be determined.

The only published comparative study of Alloderm (Preminger, et al., 2008) in breast reconstructive surgery found that Alloderm did not increase the rate of tissue expansion after tissue expander placement. This matched, retrospective cohort study compared expansion rates in patients who underwent tissue expander/implant reconstruction with Alloderm (n = 45) versus persons who underwent standard tissue expander/implant reconstruction (n = 45). Median number of expansions performed was 5 and 6 in the Alloderm and non-Alloderm cohorts (p = 0.117). The study found no difference in the mean rate of postoperative tissue expansion (Alloderm: 97 mL/injection versus non-Alloderm: 95 mL/injection [p = 0.907]).

Randomized clinical studies are ongoing of Alloderm for tissue expander implant reconstruction and for other indications (MSKCC, 2009). 

Cymetra:

Cymetra (Life Cell Corp., The Woodlands, TX) is a micronized particulate form of AlloDerm. Like AlloDerm, Cymetra is made from human allograft skin. Because of the small particle size, Cymetra can be delivered by injection as a minimally invasive tissue graft. According to the manufacturer, Cymetra is ideally suited for the correction of soft-tissue defects requiring minimally invasive techniques, such as injection laryngoplasty.

Most of the published literature on Cymetra has focused on its use in injection laryngoplasty for vocal cord paralysis (see CPB 253 -- Injections for Vocal Cord Paralysis), and its use in cosmetic soft tissue augmentation (Hirsch & Cohen, 2006; Narins & Bowman, 2005; Sclafani, et al., 2002), with the remainder of the literature addressing miscellaneous applications (Allam, 2007; Levy, et al., 2005; Banta, et al., 2003). 

E-Z Derm:

E-Z Derm (Brennen Medical Inc., St. Paul, MN) is a porcine-derived xenograft that has been chemically modified to provide durability and storage. The dermal elements from the original pig dermis are likely all deactivated in the chemical process, unlike the frozen pig dermis which is still available.  It appears that the product is a collagen scaffold.  There is very little evidence that the use of E-Z Derm is beneficial in wound healing.

In a prospective, randomized trial (n = 32), Healy and Boorman (1989) compared E-Z Derm with Jelonet as a burn dressing in patients with partial skin thickness burns.  The bacterial colonization rate, need for surgical treatment, time for spontaneous healing, analgesic requirements and frequency of dressing changes were assessed in each group.  No statistically significant differences were found between the two groups, for any of these factors.

In a controlled, prospective study (Vanstraelen, 1992), calcium sodium alginate and E-Z Derm were compared in the treatment of split-thickness skin graft donor sites on 20 patients.  Half of each donor site was dressed with each material.  Time to complete healing, quality of regenerated skin and patient comfort were evaluated.  Time to healing was 8.1 days with alginate and 11.3 days with E-Z Derm (p < 0.001).  Quality of healed skin was consistently good with the alginate, and better than under E-Z Derm in 95% of patients (p < 0.001).  Hypertrophic scarring was not observed under alginate dressings but occurred in 25% of E-Z Derm-dressed sites (p <  0.01).  Furthermore, evidence was found that allergic reactions to E-Z Derm could occur.  Alginate was preferred by 75% of patients and none preferred E-Z Derm (p < 0.01); the remainder had no preference.  The author concluded that E-Z Derm is inferior to calcium sodium alginate as a dressing for split-thickness skin donor sites.

Integra (Collagen-Glycosaminoglycan Copolymer):

Integra Dermal Regeneration Template and Integra Bilayer Wound Matrix (Integra LifeSciences Corporation, Plainsboro, NJ) are identical products; both are composed of an acellular, biodegradable collagen-glycosaminoglycan (C-GAG) copolymer matrix coated with a thin silicone elastomer.  Bovine type I collagen and chondroitin-6-sulfate, one of the major glycosaminoglycans, are co-precipitated, freeze-dried and cross-linked.  The collagen structure is manufactured.  The pore size has been determined to maximize in-growth of cells, and the degree of cross-linking as well as GAG composition, is designed to control the rate of matrix degradation.  This extra-cellular matrix analog incorporates in approximately 2 to 3 weeks forming a neodermis with new vasculature. The Integra acellular cryo-preserved allodermis is clinically used in conjunction with ultra thin (0.003 to 0.006 inch) meshed split-thickness autografts in large burn wounds.

Stern, et al. (1990) stated that Integra artificial skin is an effective means of treatment for full-thickness burns.  In this histological study, serial biopsy specimens were obtained from 131 patients during a period of 7 days to 2 years after application; 6 sequential phases of repair were discerned.  Additionally, there were occasional unusual histological features, eosinophilic infiltration, and/or macrophage-derived giant cell formation in the wound area; however, such findings did not clinically correlate with a negative response to Integra.  These investigators found that the use of Integra resulted in good repair, with rare exceptions.  An intact dermis was achieved as well as definitive closure of a complete epidermal layer with a minimum of scarring.

Dantzer and Braye (2001) presented a series of 31 patients who underwent Integra grafting for reconstructive surgery at a total of 39 operational sites.  The average area grafted per procedure was 267 cm2.  Complications (e.g., silicone detachment, failure of the graft, and hematoma) were observed in 9 cases.  The length of follow-up ranged from 0.5 to 4.0 years.  Two patients (2 sites) were lost to follow-up; the final results in the remaining patients were considered to be good in 28 cases, average in 6 cases and poor in 3 cases.  The disadvantages of using Integra in reconstructive surgery are the necessity of two operations, the risks of infection under the silicone layer, of the silicone becoming detached and of recurrence of contraction.  On the other hand, Integra has many advantages including its immediate availability, the availability of large quantities, the simplicity and reliability of the technique, and the pliability and the cosmetic appearance of the resulting cover.

Ryan, et al. (2002) examined retrospectively the mortality and length of stay (LOS) of 270 adults with acute burns greater than or equal to 20% of body surface area (BSA), and determined the effect of Integra on outcome.  No difference in mortality was found between patients who received Integra (30%; n = 43) and patients who did not (30%; n = 227).  Surviving Integra patients (n = 30) stayed longer, but they were more extensively injured than survivors who did not receive Integra (n = 158), and therefore longer hospitalizations were expected.  In a sub-group analysis, mean LOS of Integra patients with two or more mortality risk factors (age over 60 years, burn size greater than 40% BSA, or inhalation injury; n = 15) was 63 days compared with 107 days in patients with two or more risk factors (n = 29) who did not receive Integra (p = 0.014).  The authors concluded that the use of Integra in severely injured burned adults was associated with a marked decrease in LOS.

In a post-approval study, Heimbach and associates (2003) assessed the safety and effectiveness of Integra involving 216 burn injury patients who were treated at 13 burn care facilities in the United States.  The mean total body surface area burned was 36.5% (range of 1 to 95%).  Integra was applied to fresh, clean, surgically excised burn wounds.  Within 2 to 3 weeks, the dermal layer regenerated, and a thin epidermal autograft was placed.  The incidence of invasive infection at Integra-treated sites was 3.1% (95% confidence interval, 2.0 to 4.5%) and that of superficial infection 13.2% (95% confidence interval, 11.0 to 15.7%).  Mean take rate of Integra was 76.2%; the median take rate was 95%.  The mean take rate of epidermal autograft was 87.7%; the median take rate was 98%.  The authors concluded that these findings further supported the conclusion that Integra is a safe and effective treatment modality in the hands of properly trained clinicians under conditions of routine clinical use at burn centers.

Heitland and colleagues (2004) stated that the clinical use of Integra has been celebrated enthusiastically as an improvement in burn therapy over a period of more than 10 years.  Many case-reports have shown the positive effects of the treatment with Integra as a skin substitute.  In this study, these investigators examined the alterations of Integra-usage in Germany.  Fifteen German burn centers have been interviewed respectively over a time period of 6 years with interviews in the years 1999, 2001, and 2003.  The goal of this study was to focus on the problems associated with the use of artificial skin and to create a manual for Integra-therapy including indication, pre-, intra-, and post-operative treatment.  Since the first Integra Users seminar in Germany in 1999, repeated interviews have been conducted with 15 German burn centers.  The collected results of the last 6 years were evaluated.  These results demonstrated a change in the indication for the therapy with artificial skin towards extensive full thickness burned patients and as extended indication especially for post-traumatic reconstruction.  This study provided guidelines for the usage and handling of Integra and showed that Integra is an important reconstructive dermal substitute for the severely burned or post-traumatic patients if it is handled by a skilled surgeon in a correct way.

In a review on the use of Integra for full-thickness burn surgery, Fette (2005) stated that there are a lot more benefits than harms for patients.  Some of the potential benefits include no histological or immunological harms, better scar appearance, less hypertrophic scarring, less itching, better movements, thinner epidermal grafts and smaller meshes possible, immediate availability, and prolonged shelf time.  Potential harms include inability to replace both dermal and epidermal components, as well as the need for sequential operative procedures.

Integra Flowable Wound Matrix (LifeSciences Corp., Plainsboro, NJ) was cleared through the FDA 510(k) process in 2007.  It is comprised of granulated
cross-linked bovine tendon collagen and glycosaminoglycan.  The granulated collagen-glycosaminoglycan is hydrated with saline and applied in difficult to access wound sites and tunneled wounds via injection with a syringe.  It is indicated for the management of wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second degree burns, skin tears) and draining wounds; however, there is insufficient scientific evidence regarding its effectiveness for these or any other indications.

Integra Matrix Wound Dressing is comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. The collagen-glycosaminoglycan biodegradable matrix is intended to provide a scaffold for cellular invasion and capillary growth. The Integra Matrix Wound Dressing was cleared by the FDA for use in the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds. However, there is insufficient scientific evidence regarding its effectiveness for these or any other indications.

TissueMend®:

TissueMend (TEI Biosciences Inc., Boston, MA), marketed by Stryker Orthopaedics (Stryker Howmedica Osteonics, Kalamazoo, MI), is a remodelable collagen matrix derived from bovine skin and is intended for reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons; however, there is a lack of evidence in the peer reviewed medical literature to support it's clinical effectiveness.

Veritas® Collagen Matrix:

Veritas Collagen Matrix (Synovis Surgical Innovations, St. Paul, MN ) was cleared by the FDA via the 510(k) process in 2000.  It is an implantable surgical patch comprised of non-crosslinked bovine pericardium.  Veritas Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.  Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following: (i) buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchila resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus; (ii) reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding; and (iii) abdominal and thoracic wall repair, muscle flap reinforcement, rectal and vaginal prolapse repair, urinary incontinence treatment, reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).  Veritas Collagen Matrix received an additional 510(k) clearance by the FDA in 2006 and is intended to minimize tissue attachment to the device in case of direct contact with viscera.  There is insufficient scientific evidence regarding the effectiveness of Veritas Collagen Matrix for use as an implant for the surgical repair of soft tissue deficiencies or for any other indication.

NeuroMatrix^TM  Collagen Nerve Cuff:

Peripheral nerves possess the capacity of self-regeneration after traumatic injury. Transected peripheral nerves can be bridged by direct surgical coaptation of the two nerve stumps or by interposing autografts or biological (veins) or synthetic nerve conduits. Nerve conduits are tubular structures that guide the regenerating axons to the distal nerve stump. Early synthetic nerve conduits were primarily made of silicone because of the relative flexibility and biocompatibility. Nerve conduits are now made of biodegradable materials such as collagen, aliphatic polyesters, or polyurethanes (Pfister, et al., 2007).  Studies are in progress to assess the long-term biocompatibility of these implants and their effectiveness in nerve reconstruction.

According to the Collagen Matrix, Inc. (Franklin Lakes, N.J.) website, NeuroMatrix is a resorbable, semi-permeable collagen-based tubular matrix that provides a protective environment for peripheral nerve repair after injury and creates a conduit for axonal growth across a nerve gap. The device slowly resorbs in vivo. The device is engineered from highly purified type I collagen fibers and are composed of dense fibers for mechanical strength.  Collagen Nerve Cuff was cleared by the FDA via the 510(k) process in September 2001.  It is intended for use in repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity; however, there is insufficient scientific evidence regarding its effectiveness for peripheral nerve repair or for any other indication.

TenoGlide^TM Tendon Protector Sheet

TenoGlide tendon protector sheet (Tendon Wrap tendon protector, Integra LifeSciences Corp., Plainsboro, NJ) was cleared through the FDA 510(k) process in 2006.  It is an absorbable implant that provides a non-constricting, protective encasement for injured tendons and is comprised of a porous matrix of cross-linked bovine Type I collagen and glycosaminoglycan.  According to the manufacturer's website, TenoGlide provides a protective biocompatible interface, which provides a protective environment and gliding surface while the tendon is healing (e.g., tendons damaged by compression from trauma or after primary repair).  However, there is insufficient scientific evidence regarding its effectiveness for tendon repair or for any other indications.

SurgiMend®:

SurgiMend (TEI Biosciences, Boston, MA) was cleared through the FDA 510(k) process in 2007.  It is an acellular dermal tissue matrix derived from fetal bovine dermis and is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.  According to the 510(k) letter to the manufacturer, it is specifically indicated for plastic and reconstructive surgery, muscle flap reinforcement, hernia repair (e.g., abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias), reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.  It is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons.  Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.  There is insufficient scientific evidence regarding the effectiveness of SurgiMend for use as an implant for the surgical repair of soft tissue deficiencies or for any other indications.

Gammagraft Skin Substitute:

GammaGraft (Promethean LifeSciences, Pittsburgh, PA) is an irradiated human skin allograft acquired from cadaveric donors.  According to the manufacturer, its main applications are as a temporary graft for treating burns, chronic wounds, and partial and full thickness wounds (Promethean LifeSciences, 2008).  The manufacturer states that GammaGraft has both the epidermal and the dermal layers of human skin which makes it more durable and effective as a vapor barrier than most wound covers, especially some artificial skins, which lack the keratinocyte layer that is found in the epidermis.  The manufacturer states that the irradiation process that GammaGraft undergoes produces two key advantages: the irradiation acts as a preservation and sterilization agent significantly reducing any risk of viral transmission of disease and allowing Gammagraft to be stored at room temperature for up to two years. The manufacturer explains that the ability to store GammaGraft at room temperature for up to two years makes GammaGraft readily available for use upon opening a foil pack, without the need for thawing, cleansing, and rehydration. The manufacturer also states that GammaGraft can be applied in a clinical setting without incurring operating room time for application. There is a lack of evidence in the peer-reviewed published medical literature on the safety and effectiveness of Gammagraft Skin Substitute.