动物和人类临床前研究伤口报告指南。

IF 3.8 3区 医学 Q2 CELL BIOLOGY Wound Repair and Regeneration Pub Date : 2025-01-01 DOI:10.1111/wrr.13232
Nkemcho Ojeh, Nicole M Vecin, Irena Pastar, Susan W Volk, Traci Wilgus, Sarah Griffiths, Allison N Ramey-Ward, Vickie R Driver, Luisa A DiPietro, Lisa J Gould, Marjana Tomic-Canic
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引用次数: 0

摘要

伤口愈合障碍的临床前研究是将发现转化为治疗的重要步骤。此外,它们是初始安全性筛选和使用体内方法获得机制见解的组成部分。鉴于伤口愈合过程的复杂性,由于实验设计中不可避免的可变性,现有的动物试验指南不能捕捉关键信息。由于伤口病因、受伤程序、多种治疗条件、伤口评估和分析的复杂性,以及缺乏对所使用模型局限性的认识,研究解释的差异增加了。然而,目前还没有标准来指导报告在伤口愈合的转化研究中解释结果所需的关键实验信息。报告的一致性允许透明度、比较和荟萃分析研究,并避免重复和冗余。因此,对临床前伤口研究的报告进行标准化是一个至关重要且尚未得到满足的需求。为了帮助报告实验条件,作者与伤口护理协作社区(WCCC) gap小组合作创建了动物和人类临床前研究伤口报告(WRAHPS)指南,为最常用的临床前模型提供了清单和报告模板,以支持伤口愈合障碍的人类临床试验的发展。预计WRAHPS指南将对科学手稿和伤口愈合领域的综合报告方法进行标准化。本文不打算解决监管要求,但旨在为此类研究提供重要科学考虑的一般指导方针。
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The Wound Reporting in Animal and Human Preclinical Studies (WRAHPS) Guidelines.

Preclinical studies for wound healing disorders are an essential step in translating discoveries into therapies. Also, they are an integral component of initial safety screening and gaining mechanistic insights using an in vivo approach. Given the complexity of the wound healing process, existing guidelines for animal testing do not capture key information due to the inevitable variability in experimental design. Variations in study interpretation are increased by complexities associated with wound aetiology, wounding procedure, multiple treatment conditions, wound assessment, and analysis, as well as lack of acknowledgement of limitation of the model used. Yet, no standards exist to guide reporting crucial experimental information required to interpret results in translational studies of wound healing. Consistency in reporting allows transparency, comparative, and meta-analysis studies and avoids repetition and redundancy. Therefore, there is a critical and unmet need to standardise reporting for preclinical wound studies. To aid in reporting experimental conditions, The Wound Reporting in Animal and Human Preclinical Studies (WRAHPS) Guidelines have now been created by the authors working with the Wound Care Collaborative Community (WCCC) GAPS group to provide a checklist and reporting template for the most frequently used preclinical models in support of development for human clinical trials for wound healing disorders. It is anticipated that the WRAHPS Guidelines will standardise comprehensive methods for reporting in scientific manuscripts and the wound healing field overall. This article is not intended to address regulatory requirements but is intended to provide general guidelines on important scientific considerations for such studies.

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来源期刊
Wound Repair and Regeneration
Wound Repair and Regeneration 医学-皮肤病学
CiteScore
5.90
自引率
3.40%
发文量
71
审稿时长
6-12 weeks
期刊介绍: Wound Repair and Regeneration provides extensive international coverage of cellular and molecular biology, connective tissue, and biological mediator studies in the field of tissue repair and regeneration and serves a diverse audience of surgeons, plastic surgeons, dermatologists, biochemists, cell biologists, and others. Wound Repair and Regeneration is the official journal of The Wound Healing Society, The European Tissue Repair Society, The Japanese Society for Wound Healing, and The Australian Wound Management Association.
期刊最新文献
Synergistic effects of incorporated additives in multifunctional dressings for chronic wound healing: An updated comprehensive review. Kaempferol promotes flap survival by inhibiting ferroptosis and inflammation through network pharmacology and in vivo experiments. Thyroxine (T3)-mediated regulation of early cardiac repair in a chemical-induced hypoxia/reoxygenation model of adult zebrafish (Danio rerio). Recent advances in bioactive wound dressings. A novel method to assess photobiomodulation in stimulating regenerative capacity and vascularization in zebrafish.
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