Inflammatory reaction, clinical efficacy, and safety of bacterial cellulose wound dressing containing silk sericin and polyhexamethylene biguanide for wound treatment.

Bacterial cellulose wound dressings containing silk sericin and PHMB (BCSP) were developed in our previous studies. It had good physical properties, efficacy, and safety. For further use as a medical material, this dressing was investigated for its efficacy and safety in split-thickness skin graft (STSG) donor-site wound treatment compared to Bactigras® (control). Moreover, the inflammatory responses to both dressings were also deeply investigated. For in vivo study, expressions of anti-inflammatory cytokines were intensely considered in the tissue interfacing area. The result showed that IL-4 and TGF-β from BCSP-treated tissue had advantages over Bactigras®-treated tissue at 14 and 21 days post-implantation. For clinical study, a single-blinded, randomized controlled study was generated. The half of STSG donor site wound was randomly assigned to cover with BCSP or Bactigras®. Twenty-one patients with 32 STSG donor site wounds were enrolled. The results showed that wound-healing time was not significantly different in both dressings. However, wound quality of BCSP was better than Bactigras® at healing time and after 1 month (p < 0.05). The pain scores of BCSP-treated wound were statistically significant lower than Bactigras®-treated wound (p < 0.05). No sign of infection or adverse event was observed after treatment with both dressings. In conclusion, the inflammation responses of the dressing were clearly clarified. The advantages of BCSP were wound-quality improvement, pain reduction, and infection protection without adverse events. It was fit to be used as the alternative treatment of STSG donor site wound.

RCT Entities:   Population Interventions Outcomes