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タイトル: | Clinical utility of silk-elastin sponge in patients with chronic and acute skin ulcers: study protocol of a multi-center clinical trial |
著者: | Noda, Kazuo Katayama, Yasuhiro Sawaragi, Eiichi Sakamoto, Michiharu Yamanaka, Hiroki Tsuge, Itaru Katsube, Motoki https://orcid.org/0000-0001-7711-2439 (unconfirmed) Morimoto, Naoki |
著者名の別形: | 野田, 和男 片山, 泰博 澤良木, 詠一 坂本, 道治 山中, 浩気 津下, 到 勝部, 元紀 森本, 尚樹 |
キーワード: | Study protocol Wound healing Silk-elastin |
発行日: | Jan-2022 |
出版者: | Springer Nature |
誌名: | Dermatology and Therapy |
巻: | 12 |
号: | 1 |
開始ページ: | 243 |
終了ページ: | 252 |
抄録: | INTRODUCTION: Not only chronic but also some acute wounds have a risk of infection and become unhealed wounds. Silk-elastin sponge has been developed to treat chronic wounds that are susceptible to infection. Preclinical and clinical studies suggested that silk-elastin sponge is safe for humans and can promote granulation tissue formation by reducing bacterial growth in chronic wounds. The central aim of this trial is to evaluate the clinical utility and safety of silk-elastin sponge for the treatment of chronic and acute skin ulcers. METHODS: This study is a prospective, multicenter, single-arm, uncontrolled clinical trial. In this study, 20 patients with chronic ulcers and five with an acute one will be included; patients with wound infection will be excluded. Silk-elastin sponges are applied and covered with a dressing for 14 days. PLANNED OUTCOMES: The primary endpoint is the frequency of patients with chronic wounds in whom the investigator confirms the formation of a healthy wound bed at 14 days after the initial application of the study device. In addition, safety for acute wounds and handiness of the study device will be assessed. TRIAL REGISTRATION NUMBER: jRCT2052210072. |
著作権等: | © The Author(s) 2021 This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. |
URI: | http://hdl.handle.net/2433/277696 |
DOI(出版社版): | 10.1007/s13555-021-00651-4 |
PubMed ID: | 34846635 |
出現コレクション: | 学術雑誌掲載論文等 |
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