A Closer Look At Acellular Dermal Matrices For Chronic Diabetic Foot Ulcers

Andrew H. Rice, DPM, FACFAS, and Mallory Przbylski, DPM

   The lead author has published two case studies that demonstrate the positive wound healing results of the graft. The first case study involved the use of Memoderm for a non-healing, fifth digit amputation site. In this case study, only one application of Memoderm was needed to facilitate rapid epithelialization of the ulcer site, allowing closure of the wound in roughly eight weeks.9

   The second case study involved a patient with a non-healing, open guillotine transmetatarsal amputation site.10 Ninety days after applying Memoderm to the site, the lead author was able to achieve full incorporation of the graft and applied a split thickness skin graft (STSG). With full incorporation of the Memoderm product, the lead author found he could apply a much smaller STSG, leading to decreased donor site morbidity.

What You Should Know About TenSIX

TenSIX is an acellular dermal matrix product derived from human cadaveric tissue with a distinct processing technique, which sets it apart from its competitors. This product undergoes Gamma Precision Dose Sterilization to a sterility assurance level (SAL) of 106.11 The processing technique removes the epidermis and the cellular components of the tissue. This decreases the risk of an immunogenic rejection response.11

   Sterility can be defined as the absence of microorganisms, including viruses, while the sterility assurance level refers to the level of sterility obtained by processing. Currently accepted pharmaceutical sterilization levels are 106, meaning there is less than a one in one million chance that one viable microorganism will be present on the sterilized item.12,13

   TenSIX and Memoderm are unique in this aspect as they are among the only sterile acellular dermal matrices on the market. Many competing products undergo a similar processing technique to a sterility assurance level of 103, which does not meet the criteria for a sterile product. Furthermore, this processing technique does not disturb the biomechanical strength and biocompatibility of the tissue.11

   Another important characteristic of this product is the availability of a range of thicknesses (0.4-0.8 mm) that are thinner than some of the competing products on the market.11 It is our belief that the thinner grafts allow for faster vascular migration and bridging, and subsequently increase the rate of graft incorporation. TenSIX also comes in meshed and unmeshed versions, making it an acceptable product for tendon reinforcement as well.

   The lead author has had experience with this product in the form of a small case series with short-term follow up. It is the lead author’s belief that the unique qualities of the TenSIX product provide superior results with a decrease in the need for repeat graft application and re-operation/amputation rates, which also reduces costs to the patient and healthcare system.

Case Study: When A Patient With Multiple Comorbidities Has Delayed Post-Op Wound Healing

A 44-year-old female patient presented with a past medical history of type 2 diabetes mellitus, chronic renal failure on hemodialysis, peripheral vascular disease and had an angioplasty procedure on the left lower extremity. The patient has delayed post-op healing on the left fourth and fifth metatarsals after ray resections for necrotizing infection, leaving an open amputation site.

   With the patient under intravenous sedation with local anesthesia, we prepped and draped the wound with the double drape system, and marked the surgical limb. We used hydrojet debridement to remove the superficial layer of tissue and irrigated the graft application site with sterile saline solution. We then changed gowns, gloves and straps. All bleeders were under control.

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