SLR - June 2016 - David Collard

Composite Skin Grafting with Human Acellular Dermal Matrix Scaffold for Treatment of Diabetic Foot Ulcers: A Randomized Controlled Trial

Hu Z, Zhu J, Cao X, Chen C, Li S, Guo D, Zhang J, Liu P, Shi F, Tang B. Composite Skin Grafting with Human Acellular Dermal Matrix Scaffold for Treatment of Diabetic Foot Ulcers: A Randomized Controlled Trial. J Am Coll Surg. 2016: Jun;222(6): 1171-9.

Scientific Literature Review

Reviewed By: David Collard, DPM
Residency Program: Wake Forest Baptist Health

Podiatric Relevance: Patients with diabetes mellitus have a 15 to 25 percent chance of developing diabetic foot ulcers (DFU) during their lifetime and a 50 to 70 percent recurrence rate during the ensuing five years. The standard care for DFUs involves a multidisciplinary team with a key role for the podiatrist. Composite split-thickness skin grafting (STSG) with acellular dermal matrix (ADM) has been used successfully in burn injuries and trauma, but its use in treating DFUs has not been reported to date. This study investigated the efficacy of composite STSG with ADM in the treatment of DFUs and to clarify whether ADM has the capacity to prepare the wound bed and increase the survival rate of skin graft.

Methods: The study inclusion criteria were patients 18 years and older, with type 1 or type 2 diabetes, DFUs >4 weeks, Wagner’s scale stage 2 or 3, >3 cm2, (ABI 0.7–1.2). Patients with medical conditions that would impair wound healing were excluded. Subjects were randomized in a nonbiased fashion into an experimental group (human ADM scaffold and STSG; n = 26) and a control group (STSG; n = 26). All of the patients received standard care for DFUs before operating. The primary end point was the incidence of ulcer recurrence at 12 months post grafting. Secondary end points were the quality of autografted sites and complete wound healing by weeks 2, 4 and 8 post grafting.

Results: Fifty-two patients met criteria and underwent randomization. The two groups were comparable in age, sex, diabetic duration, wound duration, ABIs and wound inducement, location and size. The number of patients who experienced recurrence was significantly less in the experimental group compared with the control group (4.3 percent vs 22.7 percent). The autografted sites of the experimental group had better appearance and lower Manchester Scar Scale scores (median 9 vs median 11). Rates of complete wound closure by weeks 2, 4 and 8 were similar, as were the rates of complications by postgrafting week 4 (38.5 percent vs 26.9 percent). The two groups were similar with regard to the incidence rates of postgrafting complications, such as hematoma, infection, liquefaction and necrosis. 

Conclusions: Although the healing rate of the experimental group was not different from that of the control group, eight weeks after grafting there was a trend in the experimental group toward an improved rate of healing. ADM facilitates granular tissue formation and creates a suitable recipient wound bed for the skin graft. Composite STSG over an ADM scaffold provides an effective method to treat DFUs, with lower recurrence rates and better physical attributes compared with the traditional STSG method. Complete wound closure and complication rates were comparable between these methods. 

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