Effects of polymer oxygenated alginate dressings for healing skin graft donor areas: A phase III randomized controlled trial.

Abstract

Oxygen-generating alginate plays an important therapeutic role in wound treatment. In several studies, oxygen-generating alginate synthetic dressings have been shown to promote wound healing. We conducted a multicenter, open-label, phase III randomized clinical trial of split-thickness skin graft donor site treatment. We recruited patients with a burn size of less than 30 % total body surface area (TBSA) who required skin grafting. Patients were randomized into two groups: one group received treatment with polymer oxygenated alginate (POA) dressing (n = 69), and the other group received conventional Vaseline gauze dressing (n = 70). All patients were followed up for a predefined period until the primary outcome was assessed. The primary end point was the wound healing time. A total of 141 adult patients underwent randomization and 137 completed the trial. Wounds healed faster in the POA group than in the Vaseline gauze group (P < 0.0001). At the first five visits, wound healing rates in the POA group were higher than those in the Vaseline gauze group (P < 0.01). Pain scores were lower ( P = 0.011), and the satisfaction scores were higher (P < 0.05) in the POA group. No significant differences in wound infections and inflammation were detected between the two groups. Two adverse events occurred, but neither was related to the study products or procedures. Our results demonstrate that POA dressing is safe and clinically effective for treating split-thickness skin graft donor site wounds. It may be effective in controlling wound infection and inflammation; however, further validation is required.