Morimoto Naoki, Kakudo Natsuko, Matsui Makoto, Ogura Tsunetaka, Hara Tomoya, Suzuki Kenji, Yamamoto Masaya, Tabata Yasuhiko, Kusumoto Kenji
Department of Plastic and Reconstructive Surgery, Kansai Medical University, Osaka, Japan.
Department of Biomaterials, Field of Tissue Engineering, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan.
BMJ Open. 2015 May 11;5(5):e007733. doi: 10.1136/bmjopen-2015-007733.
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.
慢性皮肤溃疡，如糖尿病溃疡、下肢静脉溃疡和压疮，难以治愈且患病率不断上升，给医疗保健带来了高昂的成本问题。我们研发了一种明胶海绵联合疗法，能够实现富含血小板血浆（PRP）的持续释放。本研究的目的是调查水胶体敷料覆盖的自体PRP和明胶海绵覆盖的PRP治疗慢性皮肤溃疡的安全性和有效性。
招募30例经传统治疗至少1个月未愈合的慢性皮肤溃疡患者。患者在清创后接受PRP治疗，伤口用 水胶体敷料或明胶海绵覆盖。疗效将根据从开始应用PRP到二期愈合的时间，或通过相对简单的外科手术（如植皮或缝合）实现伤口闭合的日期来评估。所有患者将随访至应用后6周，以观察与PRP和敷料应用相关的不良事件。本研究旨在探讨和比较水胶体敷料覆盖的PRP与明胶海绵覆盖的PRP的安全性和有效性。如果成功，这种联合疗法可能成为含有活细胞的生物工程皮肤替代物的替代品，并在慢性皮肤溃疡的管理方面取得重大进展。
该研究方案已获得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）。本试验的结果将通过同行评审期刊、国内和国际科学会议以及向患者进行传播。
UMIN000015689。
