Exploratory clinical trial of combination wound therapy with a gelatin sheet and platelet-rich plasma in patients with chronic skin ulcers: study protocol.
Exploratory clinical trial of combination wound therapy with a gelatin sheet and platelet-rich plasma in patients with chronic skin ulcers: study protocol.
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慢性皮肤溃疡患者的明胶薄片和富含血小板的血浆结合伤口疗法的探索性临床试验：研究方案。
DOI：
10.1136/bmjopen-2015-007733
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发表时间：
2015-05-11
期刊：
影响因子：
2.9
通讯作者：
Kusumoto K
中科院分区：
文献类型：
--
作者：
Morimoto N;Kakudo N;Matsui M;Ogura T;Hara T;Suzuki K;Yamamoto M;Tabata Y;Kusumoto K
慢性皮肤溃疡，如糖尿病性溃疡、静脉性腿部溃疡和压力性溃疡，是难治性的并且患病率增加，代表了医疗保健中的昂贵问题。我们开发了一种与明胶片的联合治疗，能够提供富血小板血浆（PRP）的持续释放。本研究旨在研究水胶体敷料覆盖的自体PRP和明胶片覆盖的PRP治疗慢性皮肤溃疡的安全性和有效性。招募了30名患有慢性皮肤溃疡的患者，这些患者至少1个月没有用常规疗法治愈。患者将在清创后接受PRP，伤口将用水胶体敷料或明胶片覆盖。将根据从PRP应用开始到二次愈合的时间或通过相对简单的外科手术（如植皮或植皮）实现伤口闭合的日期评价疗效。所有患者将随访至贴敷后6周，以观察与PRP和敷料贴敷相关的不良事件。 本研究旨在讨论并比较水胶体敷料与明胶片覆盖的PRP的安全性和有效性。如果成功的话，这种联合疗法可能成为含有活细胞的生物工程皮肤替代品的替代品，并导致慢性皮肤溃疡管理的实质性进展。研究方案获得了关西医科大学机构审查委员会的批准（KMU编号0649-1，2014年8月4日：V.1.0）。这项试验的结果将通过同行评审期刊、国家和国际科学会议以及患者传播。UMIN000015689。
Chronic skin ulcers, such as diabetic ulcers, venous leg ulcers and pressure ulcers, are intractable and increasing in prevalence, representing a costly problem in healthcare. We developed a combination therapy with a gelatin sheet, capable of providing sustained release of platelet-rich plasma (PRP). The objective of this study is to investigate the safety and efficacy of autologous PRP covered with a hydrocolloid dressing and PRP covered with a gelatin sheet in the treatment of chronic skin ulcers. Thirty patients with chronic skin ulcers who have not healed with conventional therapy for at least 1 month are being recruited. The patients will receive PRP after debridement, and the wounds will be covered with a hydrocolloid dressing or gelatin sheet. The efficacy will be evaluated according to the time from the beginning of PRP application to secondary healing or the day on which wound closure is achieved with a relatively simple surgical procedure, such as skin grafting or suturing. All patients will be followed up until 6 weeks after application to observe adverse events related to the application of PRP and the dressings. This study was designed to address and compare the safety and efficacy of PRP covered with a hydrocolloid dressing versus a gelatin sheet. If successful, this combination therapy may be an alternative to bioengineered skin substitutes containing living cells and lead to substantial progress in the management of chronic skin ulcers. The study protocol was approved by the Institutional Review Board of Kansai Medical University (KMU Number 0649-1, 4 August 2014: V.1.0). The findings of this trial will be disseminated through peer-reviewed journals, and national and international scientific meetings as well as to the patients. UMIN000015689.
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影响因子：
3.6
作者：
Kakudo, Natsuko;Minakata, Tatsuya;Kusumoto, Kenji
通讯作者：
Kusumoto, Kenji
影响因子：
2.4
作者：
Doerler, Martin;Eming, Sabine;Stuecker, Markus
通讯作者：
Stuecker, Markus
影响因子：
3.1
作者：
Setta, Hany Saad;Elshahat, Ahmed;Safe, Ikram
通讯作者：
Safe, Ikram
影响因子：
1.3
作者：
Kushida, Satoshi;Kakudo, Natsuko;Kusumoto, Kenji
通讯作者：
Kusumoto, Kenji
影响因子：
1.5
作者：
Morimoto, Naoki;Takemoto, Satoru;Suzuki, Shigehiko
通讯作者：
Suzuki, Shigehiko