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  Title	A prospective multicenter phase III clinical trial evaluating the efficacy and safety of silk elastin sponge in patients with skin defects
  ID	8124978
  External ID	7674194338
  Author	Unknown
  Published Date	April 2, 2025, 6:31 a.m.
  Summary	Study setting This was a prospective, multicenter, single-arm, uncontrolled clinical trial (registration no. jRCT2052210072, registered on 11/07/2023). All individuals participating in this study adh
  Tags	None
  URL	https://www.nature.com/articles/s41598-025-88150-w
  Sentiment	Negative: 0.03156    Neutral: 0.93785    Positive: 0.03059
  Relevance	0.00394

• Content Details

  Content ID	5430224
  Key	786a2b20-5a31-4b6a-ac1c-061dca8e61e8
  Content	Study setting This was a prospective, multicenter, single-arm, uncontrolled clinical trial (registration no. jRCT2052210072, registered on 11/07/2023). All individuals participating in this study adhered to the ethical principles outlined in the Declaration of Helsinki and complied with relevant laws, regulations, and international standards, including ISO 14155:2020, which pertain to clinical trials of medical devices. The target number of cases was 20 chronic wounds and five acute wounds. The different types of wounds, pre-study treatment, interventions, and assessments are summarized in the study design flowchart (Fig. 2) and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) (Fig. 3). Written informed consent was obtained from all patients. The participants were treated with SE-P47K-WAS for 14 d and observed for another 14 d to evaluate the course of wound healing and adverse events. Previously reported inclusion and exclusion were utilized23. A summary of these criteria is provided in Fig. 4. Fig. 3 SPIRIT figure. Schedule of enrollment, interventions, and assessments. Full size image Fig. 4 Study inclusion, exclusion, and discontinuation criteria. Full size image This study was conducted at nine hospitals in Japan: Kyoto University Hospital (Kyoto); Tokyo Medical University Hospital (Tokyo); Juntendo University Hospital (Tokyo); Kansai Medical University Hirakata Hospital (Osaka); Kobe University Hospital (Kobe); Hakodate Central General Hospital (Hakodate); Yao Tokushukai General Hospital (Osaka); Oita Oka Hospital (Oita); and Tokyo-Nishi Tokushukai Hospital (Tokyo). Institutional Review Board (IRB) approval was obtained from all investigational sites for the design and modification of the study. Study schedule For chronic wounds, only patients with a wound area reduction of less than 50% after 28 days of standard treatment prior to entry were considered eligible. After taking pictures of the wound at the beginning of treatment, the target wound was debrided under appropriate anesthesia to remove non-viable tissue. After hemostasis and washing with saline solution, a sheet of SE-P47K-WAS trimmed to fit the wound’s shape was applied to the wound and covered with a wound dressing, which was selected from one of the following four options: polyurethane film dressing (3 M TegadermⓇ Transparent Film Dressing; 3 M, Maplewood, Minnesota, USA), silicone-faced wound dressing (SI-AidⓇ; ALCARE, Tokyo, Japan), low-adherent absorbent dressing (MelolinⓇ; Smith & Nephew, Hull, UK), or polyurethane form dressing (HydrositeⓇ thin type; Smith & Nephew). The wound was secured using appropriate external fixation. If, after debridement, it was anticipated that the conditions would not be appropriate for SE-P47K-WAS hydrogel formation owing to bleeding or an excessive amount of exudate, the wound was temporarily covered with a wound dressing or ointment without applying SE-P47K-WAS. In such instances, SE-P47K-WAS was applied on the day after surgery. Antibiotics were administered intravenously on the day of surgery. After seven days, the wound dressing was removed, and the wound was assessed and photographed. Subsequently, the wound was washed with saline solution, and a new SE-P47K-WAS was applied unless there was already sufficient granulation and did not require additional application. SE-P47K-WAS was maintained on the wound surface for 14 days (± 2 days) after the initial application, with or without additional application. After this period, conventional treatment was administered following the removal of SE-P47K-WAS, and the wound was observed until day 28. No further application of SE-P47K-WAS was permitted during the observation period. Drugs and devices prohibited for use in combination with the study device From enrollment to the end of the 28-day observation period, the application of NPWT, basic fibroblast growth factor solution, and artificial dermal substitutes (e.g. PelnacⓇ) on the target wound was strictly prohibited. The utilization of prostaglandin preparations, prostaglandin ointment, dibutyryl cyclic AMP ointment, and tretinoin tocopheril ointment is limited to long-term chronic use only. The use of the topically administered drugs or therapies mentioned above at sites other than the target wound was not restricted. This was performed to prevent any difficulties in evaluating the clinical efficacy of SE-P47K-WAS using these agents, which promote granulation formation, epithelial growth, and angiogenic properties. Antimicrobials were prohibited except for administration on the day of the surgery. Primary and secondary endpoints The primary endpoint in the chronic wound group was the percentage of patients who attained the status of a “well-prepared wound” (WPW) 14 days after the initial application of SE-P47K-WAS. WPW was defined as a wound that was ready for closure using simple surgical procedures, such as skin grafts, skin flaps, simple sutures, or through secondary healing. In other words, wounds had to meet the following three criteria: “healthy granulation tissue” covering at least 80% of the wound, less than 5% of necrotic tissue, and no obvious signs of infection. The secondary endpoints were as follows: (1) the percentage of patients who attained a WPW at days 7, 21 and 28 for chronic wounds, and at days 7, 14, 21 and 28 for acute wounds; (2) the wound area ratio (wound area at observation divided by wound area after debridement) at 7, 14, 21, and 28 days after the initial application of SE-P47K-WAS for chronic wounds; (3) the healthy granulation area ratio (healthy granulation area divided by wound area) at 7, 14, 21, and 28 days after the initial application of SE-P47K-WAS for chronic wounds; (4) the healthy granulation assessment score (Supplementary Table S1) frequency at after debridement, 7, 14, 21, and 28 days after the initial application of SE-P47K-WAS for chronic wounds; (5) the frequency of applying SE-P47K-WAS to each patient; (6) the accessibility of SE-P47K-WAS assessed through a questionnaire survey (Supplementary Table S2) conducted by the investigators at the end of the observation period. Secondary endpoints (2), (3), (4) were evaluated only for chronic wounds. Safety endpoints The safety endpoints were as follows: (1) the incidence of adverse events, where adverse events were defined as medically unfavorable events that could not be attributed to the study intervention; (2) study equipment failure; (3) the incidence of local symptoms related to inflammation or infection, including redness, heat, swelling, pain exacerbation, increased exudate, exudate cloudiness, and malodor at each time point; and (4) abnormal results from blood tests, wound bacterial cultures, and vital signs observed at each time point. Evaluation of wound bed, wound area, and healthy granulation area Digital photographs of the wounds were captured using a calibrator (Casmatch; Bear Medical, Tokyo, Japan). Their color and size were calibrated according to the manufacturer’s instructions, and the size of the area was measured using a raster graphics editor (Adobe Photoshop; Adobe, San Jose, California, USA). The achievement of the WPW was evaluated by the investigators at each institute. To this end, the wound area was measured using photographs taken by three independent plastic surgeons without any involvement in the treatment process. The post-debridement wound area was used as the baseline to determine the percentage of the wound area on days 7, 14, 21, and 28 after application. Moreover, the formation of granulation tissue was evaluated using two methods: (1) Healthy Granulation Assessment Score: The investigators at each institute assessed the score (ranging from 0 to 6, Supplementary table S1) on days 0 (after debridement), 7, 14, 21, and 28; (2) Healthy Granulation Area Ratio: The percentage of healthy granulation area was assessed by three independent plastic surgeons and calculated by dividing the healthy granulation area by the wound area at each time point. Statistical analysis Analysis set The study population analyzed for efficacy was the full analysis set (FAS). For the primary endpoint, a reference analysis of the per protocol set (PPS) was also performed. The safety analysis population comprises the safety analysis set (SAS). FAS was defined as the population of subjects enrolled in the study to whom the device was applied at least once and for whom the necessary efficacy data were available. The PPS was defined as the population of participants in the FAS with no significant violations of the study protocol. A significant violation of the protocol is defined in Supplementary Table S3. SAS was defined as the number of subjects enrolled in the study to whom the device was applied at least once. Descriptive statistical analysis was conducted to determine summary statistics and to express 95% confidence intervals for each survey item. Monitoring and audit Regular monitoring by a Clinical Research Associate (CRA) was conducted to ensure that the study was conducted in accordance with the study protocol, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements. Auditing Independent audits were conducted by a third-party accepting agency, and these audits confirmed compliance with regulatory requirements, study protocols, and ethical guidelines.
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  Publisher Name	Nature
  Publisher URL	https://www.nature.com/
  Description	None
  Trust Flow Score	61
  Citation Flow Score	58

• Data Source

  Data Source Name	Quantexa News
  Data Source Type	news
  Data Source URL	https://app.aylien.com/dashboard
  Description	Welcome to Quantexa News API — the most powerful way to aggregate, filter, and integrate global news data into your apps and models.
  Weight	10