Clinical Potential of a Silk Sericin-Releasing Bioactive Wound Dressing for the Treatment of Split-Thickness Skin Graft Donor Sites

Purpose An ethyl alcohol-precipitated silk sericin/PVA scaffold that controlled the release of silk sericin was previously developed and applied for the treatment of full-thickness wounds in rats and demonstrated efficient healing. In this study, we aimed to further evaluate the clinical potential of this scaffold, hereafter called silk sericin-releasing wound dressing, for the treatment of split-thickness skin graft donor sites by comparison with the clinically available wound dressing known as BactigrasA (R). Methods In vitro characterization and in vivo evaluation for safety of the wound dressings were performed. A clinical trial of the wound dressings was conducted according to standard protocols. Results The sericin released from the wound dressing was not toxic to HaCat human keratinocytes. A peel test indicated that the silk sericin-releasing wound dressing was less adhesive than BactigrasA (R), potentially reducing trauma and the risk of repeated injury upon removal. There was no evidence of skin irritation upon treatment with either wound dressing. When tested in patients with split-thickness skin graft donor sites, the wounds treated with the silk sericin-releasing wound dressing exhibited complete healing at 12 A +/- 5.0 days, whereas those treated with BactigrasA (R) were completely healed at 14 A +/- 5.2 days (p = 1.99 x 10(-4)). In addition, treatment with the silk sericin-releasing wound dressing significantly reduced pain compared with BactigrasA (R) particularly during the first 4 postoperative days (p = 2.70 x 10(-5) on day 1). Conclusion We introduce this novel silk sericin-releasing wound dressing as an alternative treatment for split-thickness skin graft donor sites.