Point-Counterpoint: Are Acellular Dermal Matrices More Effective Than Fibroblast-Derived Dermal Substitutes?

Author(s): 
Howard Kimmel, DPM, and Alexander Reyzelman, DPM

Graft Applications And Healing: What The Research Reveals

There is level 2 evidence on both fibroblast-derived dermal substitutes and human acellular dermis. There are a total of seven studies published on fibroblast-derived dermal substitutes. Marston and coworkers published a study that was based on a multicenter randomized controlled trial, which enrolled a total of 245 patients.5 The study compared a fibroblast-derived dermal substitute to a control of wet-to-dry dressings along with proper wound treatment with a primary endpoint of 12 weeks. In this trial, the results show an increased incidence of complete ulcer healing of 30 percent in the fibroblast-derived dermal substitutes versus 18.3 percent in the control group. The authors noted a faster time to closure for the fibroblast-derived dermal substitute. This study did not list the average number of grafts needed for closure but the study authors stated that researchers used up to eight grafts.

   Veves and colleagues looked at a bilayered, fibroblast-derived dermal substitute.6 This trial enrolled a total of 208 randomized patients in a multicenter study. The results showed a significant benefit for bilayered, fibroblast-derived dermal substitutes in complete ulcer healing at 12 weeks: 56 percent versus 38 percent for the control group and a median time to closure of 65 days versus 90 days for control. The authors noted one could use up to five grafts per patient but they used an average of 3.9 grafts per patient.

   Iorio and coworkers did a systemic review of human acellular dermal matrices utlilizing both Medline and the Cocharane Database.7 They found a total of five papers published with a total of 299 patients enrolled in studies. A total of three papers had either level 1 or 2 evidence.

   In 2004, Brigido and coworkers performed a single center prospective study on 40 patients with full thickness wounds.8 These patients were randomized to receive either human acellular dermal matrix or sharp debridement and wound gel. The endpoint was evaluation of wound reduction at four weeks. In the human acellular dermal matrix group, there was a 73.1 percent wound reduction in comparison to 25 percent in the control group.

   In their next study, Brigido and colleagues performed a randomized prospective single center study on patients with a total of 28 full-thickness diabetic ulcers that had a duration of longer than six weeks without any epidermal coverage.9 The randomization was the same as the authors’ previous study. There was offloading for plantar ulcers in both groups. The wound gel group had weekly dressing changes while the human acellular dermal group only had one application and interval dressing changes. The results at 16 weeks demonstrated complete wound healing in 86 percent of the human acellular dermal group and 29 percent in the control group.

   Reyzelman and coworkers published the most significant paper on acellular dermal regenerative tissue matrix in 2009.10 The authors conducted a prospective, randomized, controlled multicenter trial over a 12-week period on a total of 86 patients. All had sharp debridement and offloading when needed. Forty-one patients randomized to the human acellular dermal matrix group completed the trial with 70 percent progressing to complete healing at an average of approximately six weeks. There were 37 patients in the control group with 46 percent progressing to complete healing at an average of seven weeks. The odds ratio for the patients to heal was 2.7 times higher than the control group. In all three studies, researchers used only one application of human acellular dermis.

Final Words

In my opinion, both products have their role in wound care. There is evidence to show that these products work. It comes down to the number of applications, cost of the product, the strength of the evidence and ease of use. In this case, human acellular dermal matrix has the advantage.

   Dr. Kimmel is a Diplomate of the American Board of Podiatric Surgery. He is the Director of Residency Training at the Department of Veterans Affairs in Cleveland, Ohio. Dr. Kimmel is the Senior Clinical Instructor in the Department of Surgery at Case Western Reserve University School of Medicine in Cleveland.

Comments

And how much does all this cost the patient or insurance company? Do you think this will be covered in those patients with the cheapest Obama care plans? Buehler? Buehler? Hello?
Will podiatry continue this treatment when it is no longer reimbursable? Oh, it really wasn't all that effective anyway.

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