Abstract:
Sericin dressing containing collagen hydrolysate (SDC) was evaluated in this study, consisting of two phases of clinical trials. The clinical safety of SDC was determined using a patch test in 103 healthy volunteers (phase I). Most of the results (around 90%) in the SDC group were interpreted as negative and doubtful reactions, and the remaining results (around 10%) were weak reactions. After that, the clinical efficacy and safety of SDC were investigated in 21 patients with 30 split-thickness skin graft (STSG) donor sites (phase II). Each donor site was divided into two equal sites. SDC or the commercial dressing (Bactigras®) was randomly applied as the primary dressing at each site. It was found that SDC (15.00 ± 7.00 days) significantly reduced the wound healing time when compared to Bactigras® (16.00 ± 8.00 days), p=0.015. The scar quality after complete healing were also examined by both subjective (Vancouver scar scale; VSS and patient part of Patient and Observer Scar Scale; POSAS) and objective methods (Mexameter®, Tewameter®, Corneometer®, and Cutometer®). The findings from all measurements at 0, 1, 3, and 6 months seemingly agree that SDC could improve the scar quality. The darkness and redness of the scar appear to be better in the SDC group. The scar pliability evaluated by VSS in SDC treated sites was also preferable to Bactigras® treated sites. Moreover, the recovery of epidermal functions and scar maturation might be enhanced by SDC. The patient’s satisfaction in SDC treated site also seems to be superior to the control-treated site. The pain scores in both dressings were relatively low and comparable. There was no infection and adverse effects in both dressings’ applications. The moisture control and the synergistic effects from sericin and collagen hydrolysate might facilitate STSG donor healing, leading to faster healing and better scar quality. Accordingly, it can be concluded that SDC is possibly used as the alternative dressing for STSG donor sites.
