Comparative clinical efficacy of wound dressing containing silk fibroin with bioactive coating layer versus medicated paraffin gauze dressing in the treatment of split-thickness skin graft donor sites

Abstract

The objectives of this study were to evaluate the safety and efficacy of wound dressing containing silk fibroin with bioactive coating layer in healthy volunteers using a skin patch test and in the treatment of Split-Thickness Skin Graft (STSG) donor sites compared with commercially available medicated paraffin gauze dressing, Bactigras®, a standard treatment. Each back of 110 healthy volunteers was divided into the left and right sides and was randomized to receive the wound dressing containing silk fibroin with bioactive coating layer or Bactigras®. Both dressings were left for 3 days. After that, both dressings were changed and left for an additional 3 days. Seven to ten days later, both dressings were applied on the identical areas and left in place for 3 days. There was no evidence of skin irritation measured by Mexameter MX18®. Although, the results obtained from the Repeated Insult Patch Test (RIPT) scale revealed there was evidence of mild and moderate erythema in the wound dressing containing silk fibroin with bioactive coating layer group (3.64%), this evidence was comparable to the commercial wound dressing. Each donor site of 30 split-thickness skin graft donor sites from 23 patients was divided into the upper and lower sides and was randomized to receive wound dressing containing silk fibroin with bioactive coating layer or Bactigras®. The results showed that the healing time of STSG donor sites treated with the wound dressing containing silk fibroin with bioactive coating layer (11.0 ± 6.0 days) was significantly faster than that treated with Bactigras® (14.0 ± 6.0 days) (p=10-6). The sides treated with the wound dressing containing silk fibroin with bioactive coating layer showed significantly less pain (p ≤ 10-4) and more rapid recovery in the water barrier function (p = 10-5) than those treated with Bactigras® on all evaluation days. There were no signs of STSG donor site infection in either wound dressing group. AST, ALT, ALP, albumin, BUN and Scr were decreased after operation; however, the median of all parameters was in the normal range. The morphology of epithelial cells attached on the wound dressing containing silk fibroin with bioactive coating layer after falling off spontaneously under the microscope showed a definite border of cells, indicating a better shape of epithelial cells. In conclusion, wound dressing containing silk fibroin with bioactive coating layer can be used as optional treatment for STSG donor sites due to an acceptable safety profile in healthy volunteers and its promotion of wound healing and minimizing pain without adverse effects in the treatment of STSG donor sites.