A prospective multicenter phase III clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defects
Abstract 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 effic...
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Nature Portfolio
2025-04-01
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| Series: | Scientific Reports |
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| Online Access: | https://doi.org/10.1038/s41598-025-88150-w |
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| author | Eiichi Sawaragi Michiharu Sakamoto Yasuhiro Katayama Shingo Kawabata Satoshi Somamoto Kazuo Noda Naoki Morimoto |
| author_facet | Eiichi Sawaragi Michiharu Sakamoto Yasuhiro Katayama Shingo Kawabata Satoshi Somamoto Kazuo Noda Naoki Morimoto |
| author_sort | Eiichi Sawaragi |
| collection | DOAJ |
| description | Abstract 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 ). |
| format | Article |
| id | doaj-art-8db95b753b884ababeb4a3ef3d20361d |
| institution | DOAJ |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Nature Portfolio |
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| spelling | doaj-art-8db95b753b884ababeb4a3ef3d20361d2025-08-20T03:07:41ZengNature PortfolioScientific Reports2045-23222025-04-0115111210.1038/s41598-025-88150-wA prospective multicenter phase III clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defectsEiichi Sawaragi0Michiharu Sakamoto1Yasuhiro Katayama2Shingo Kawabata3Satoshi Somamoto4Kazuo Noda5Naoki Morimoto6Department of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto UniversityDepartment of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto UniversityDepartment of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto UniversityKatsura Research Laboratory, Sanyo Chemical Industries, Ltd.Katsura Research Laboratory, Sanyo Chemical Industries, Ltd.Department of Plastic Surgery, Tenri HospitalDepartment of Plastic and Reconstructive Surgery, Graduate School of Medicine, Kyoto UniversityAbstract 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 ).https://doi.org/10.1038/s41598-025-88150-wWound healingRecombinant proteinSilk-elastin spongeChronic woundAcute woundClinical trial |
| spellingShingle | Eiichi Sawaragi Michiharu Sakamoto Yasuhiro Katayama Shingo Kawabata Satoshi Somamoto Kazuo Noda Naoki Morimoto A prospective multicenter phase III clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defects Scientific Reports Wound healing Recombinant protein Silk-elastin sponge Chronic wound Acute wound Clinical trial |
| title | A prospective multicenter phase III clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defects |
| title_full | A prospective multicenter phase III clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defects |
| title_fullStr | A prospective multicenter phase III clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defects |
| title_full_unstemmed | A prospective multicenter phase III clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defects |
| title_short | A prospective multicenter phase III clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defects |
| title_sort | prospective multicenter phase iii clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defects |
| topic | Wound healing Recombinant protein Silk-elastin sponge Chronic wound Acute wound Clinical trial |
| url | https://doi.org/10.1038/s41598-025-88150-w |
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