PDF(Pubmed)
Abstract：
BACKGROUND: Burn-related injuries are a major global health issue, causing 180,000 deaths per year. Early debridement of necrotic tissue in association with a split-thickness skin graft is usually administered for some of the 2nd- and 3rd-degree injuries. However, this approach can be complicated by factors such as a lack of proper donor sites. Artificial skin substitutes have attracted much attention for burn-related injuries. Keratinocyte sheets are one of the skin substitutes that their safety and efficacy have been reported by previous studies.
METHODS: Two consecutive clinical trials were designed, one of them is phase I, a non-randomized, open-label trial with 5 patients, and phase II is a randomized and open-label trial with 35 patients. A total number of 40 patients diagnosed with 2nd-degree burn injury will receive allogenic keratinocyte sheet transplantation. The safety and efficacy of allogeneic skin graft with autograft skin transplantation and conventional treatments, including Vaseline dressing and topical antibiotic, will be compared in different wounds of a single patient in phase II. After the transplantation, patients will be followed up on days 3, 7, 10, 14, 21, and 28. In the 3rd and 6th months after the transplantation scar, a wound closure assessment will be conducted based on the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale.
CONCLUSIONS: This study will explain the design and rationale of a cellular-based skin substitute for the first time in Iran. In addition, this work proposes this product being registered as an off-the-shelf product for burn wound management in the country.
BACKGROUND: Iranian Registry of Clinical Trials (IRCT) IRCT20080728001031N31, 2022-04-23 for phase I and IRCT20080728001031N36, 2024-03-15 for phase II.
METHODS: Two consecutive clinical trials were designed, one of them is phase I, a non-randomized, open-label trial with 5 patients, and phase II is a randomized and open-label trial with 35 patients. A total number of 40 patients diagnosed with 2nd-degree burn injury will receive allogenic keratinocyte sheet transplantation. The safety and efficacy of allogeneic skin graft with autograft skin transplantation and conventional treatments, including Vaseline dressing and topical antibiotic, will be compared in different wounds of a single patient in phase II. After the transplantation, patients will be followed up on days 3, 7, 10, 14, 21, and 28. In the 3rd and 6th months after the transplantation scar, a wound closure assessment will be conducted based on the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale.
CONCLUSIONS: This study will explain the design and rationale of a cellular-based skin substitute for the first time in Iran. In addition, this work proposes this product being registered as an off-the-shelf product for burn wound management in the country.
BACKGROUND: Iranian Registry of Clinical Trials (IRCT) IRCT20080728001031N31, 2022-04-23 for phase I and IRCT20080728001031N36, 2024-03-15 for phase II.
摘要：
背景：与烧伤有关的伤害是一个主要的全球健康问题，每年造成18万人死亡。对于某些2度和3度损伤，通常会对坏死组织进行早期清创术，并进行厚薄的皮肤移植。然而,这种方法可能会因缺乏适当的供体地点等因素而变得复杂。人工皮肤替代品在烧伤相关损伤方面备受关注。角质形成细胞片是皮肤替代品之一，其安全性和有效性已被先前的研究报道。
方法：设计了两个连续的临床试验，其中一个是第一阶段,一个非随机的，5名患者的开放标签试验，II期是一项随机和开放标签试验，共有35名患者。总共有40名被诊断为2度烧伤的患者将接受同种异体角质形成细胞片移植。同种异体皮肤移植与自体皮肤移植和常规治疗的安全性和有效性，包括凡士林敷料和局部抗生素，将在II期单个患者的不同伤口中进行比较。移植后,患者将在第3,7,10,14,21和28天接受随访.在移植后的第3个月和第6个月，将根据温哥华疤痕量表和患者和观察者疤痕评估量表进行伤口闭合评估。
结论：这项研究将首次在伊朗解释基于细胞的皮肤替代品的设计和原理。此外,这项工作建议将该产品注册为该国烧伤伤口管理的现成产品。
背景：伊朗临床试验注册（IRCT）IRCT20080728001031N31，2022-04-23用于I期，IRCT20080728001031N36，2024-03-15用于II期。
方法：设计了两个连续的临床试验，其中一个是第一阶段,一个非随机的，5名患者的开放标签试验，II期是一项随机和开放标签试验，共有35名患者。总共有40名被诊断为2度烧伤的患者将接受同种异体角质形成细胞片移植。同种异体皮肤移植与自体皮肤移植和常规治疗的安全性和有效性，包括凡士林敷料和局部抗生素，将在II期单个患者的不同伤口中进行比较。移植后,患者将在第3,7,10,14,21和28天接受随访.在移植后的第3个月和第6个月，将根据温哥华疤痕量表和患者和观察者疤痕评估量表进行伤口闭合评估。
结论：这项研究将首次在伊朗解释基于细胞的皮肤替代品的设计和原理。此外,这项工作建议将该产品注册为该国烧伤伤口管理的现成产品。
背景：伊朗临床试验注册（IRCT）IRCT20080728001031N31，2022-04-23用于I期，IRCT20080728001031N36，2024-03-15用于II期。
