A prospective multicenter phase III clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defects

Silk elastin sponge, a novel recombinant protein used for wound healing, has been shown to be effective in promoting macrophage migration, epithelial growth, granulation, and angiogenesis in both preclinical (in vitro and in vivo) and clinical studies. This study aimed to evaluate the efficacy and safety of silk elastin sponges in the treatment of chronic and acute wounds. A prospective multicenter, single-arm, uncontrolled clinical trial included 20 patients with chronic wounds and five with acute wounds, applying the sponge after debridement. The primary endpoints were the percentage of patients with chronic wounds and well-prepared wound beds after 14 days of treatment. The safety of the procedure was also assessed. The results showed that 90.0% of chronic wound patients had well-prepared wound beds by day 14, and 24 out of 25 patients completed the treatment, with one case discontinued due to local infection. This study concluded that silk elastin sponges may be an effective new option for wounds that are unresponsive to existing treatments. Trial registration: jRCT2052210072. Registered on 11 July 2023 in the Japan Registry of Clinical Trials (http://jrct.niph.go.jp).