A bilayered living skin construct (APLIGRAF®) accelerates complete closure of hard‐to‐heal venous ulcers

TLDR

In a prospective, randomized controlled trial of 120 patients with venous leg ulcers lasting over a year, Graftskin plus compression therapy was compared to compression alone, with outcomes measured by the proportion and time to complete wound closure. Graftskin treatment achieved a 47% healing rate at 6 months versus 19% with compression alone, was twice as likely to close wounds by 6 months, and was over 60% more effective overall, demonstrating its efficacy for chronic venous ulcers.

Abstract

The efficacy of a bilayered, living skin construct (APLIGRAF(R) [Graftskin]) was evaluated in patients (n = 120) with hard- to-heal venous leg ulcers of greater than 1 year's duration. The study was prospective, randomized, and controlled. Patients received Graftskin plus compression therapy, or standard compression therapy (active control). Patients were evaluated for frequency and time to complete (100%) wound closure. Treatment with Graftskin was significantly more effective than active control in the percentage of patients healed by 6 months (47% vs. 19%; p < 0.005) and the median time to complete wound closure (p < 0.005). Analysis with multivariate regression methods, adjusting for factors generally thought to influence wound healing (duration, baseline area, depth, location, fibrinous wound bed, and infection), showed that patients treated with Graftskin were twice as likely to achieve complete wound closure by 6 months (p < 0.005), and over 60% more effective in achieving wound closure than active control (p < 0.01). These data indicate that Graftskin is an effective treatment for venous ulcers of greater than 1 year's duration.