Abstract:
A biocellulose wound dressing composed of silk sericin as an accelerative wound healing component and polyhexamethylene biguanide (PHMB) as an antimicrobial agent which showed effective and safe wound treatment. A prospective, single-blinded, randomized controlled matched-pair study was designed to evaluate the safety and the clinical efficacy of the biocellulose wound dressing containing silk sericin and PHMB compared with Bactigras® in healthy volunteers (phase I clinical study) and in split-thickness skin graft (STSG) donor site wound treatment (phase II clinical study). There were 105 healthy volunteers in phase I clinical study. The results showed that the erythema and melanin levels of skin covered with both dressings were not significantly different. In the phase II clinical study, 21 patients with 32 STSG donor site wounds were included in the study. The wound healing time was not significantly different between dressings. The melanin levels, erythema levels, and TEWL levels of the group treated with the biocellulose wound dressing were significantly lower than the control group. No signs of infection and adverse effect were observed in wounds covered with either dressing. The pain scores of wounds covered with the biocellulose wound dressing were significantly lower than Bactigras® at days 1 to 5. In conclusion, the biocellulose wound dressing containing silk sericin and PHMB exhibits safety and many benefits including high scar quality, pain reduction, infection protection without adverse events. It is appropriate for use as an alternative treatment for STSG donor site wounds.
