Artificial dermis for major burns. A multi-center randomized clinical trial

Area of Science:

• Regenerative Medicine
• Biomaterials Science
• Burn Surgery

Background:

• Severe burns necessitate advanced wound healing strategies.
• Current skin grafting techniques have limitations in donor site morbidity and scarring.
• The Burke-Yannas artificial dermis offers a potential solution for extensive skin loss.

Purpose of the Study:

• To evaluate the efficacy and safety of the artificial dermis compared to conventional grafting methods in patients with severe burns.
• To assess graft take, donor site characteristics, and long-term outcomes including scarring and patient satisfaction.

Main Methods:

• An 11-center prospective randomized trial involving 106 patients with severe burns (mean 46.5% TBSA).
• Comparable burn sites were randomized to receive either artificial dermis or standard grafting materials (autograft, allograft, xenograft, synthetic dressing).
• Epidermal grafting was performed on the artificial dermis site, with follow-up for 1 year.

Main Results:

• Median artificial dermis graft take was 80%, comparable to non-autograft controls.
• Study sites used significantly thinner donor grafts (.006'' vs .013'', p<0.0001).
• Epidermal donor sites healed 4 days faster (10 vs 14 days, p<0.0001), with less hypertrophic scarring and greater patient preference for the artificial dermis.

Conclusions:

• Artificial dermis with epidermal grafting is a satisfactory permanent skin cover for severe burns.
• This technique offers advantages in reduced donor graft thickness and accelerated donor site healing.
• The artificial dermis demonstrates comparable functional and aesthetic outcomes to traditional methods, with improved patient satisfaction.