Dukaew Nahathai, Sakuludomkan Wannachai, Na Takuathung Mingkwan, Pruksakorn Dumnoensun, Punyodom Winita, Koonrungsesomboon Nut
Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Musculoskeletal Science and Translational Research Center (Mstr), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Expert Rev Med Devices. 2022 Mar;19(3):247-258. doi: 10.1080/17434440.2022.2054333. Epub 2022 Mar 23.
Clinical trials are a prerequisite for any investigational suture materials before a market approval application. The appropriate study designs and primary outcome measures are key to the validity and reliability of clinical trial results. This study aimed to characterize the study designs and primary outcome measures being applied in clinical trials of investigational suture materials.
The systematic searches on PubMed, EMBASE, Web of Sciences, Scopus, and Cochrane databases were conducted to gather relevant studies published between January-2019 and May-2021. Data on general characteristics, suture intervention, study design, and primary outcome measures were extracted and analyzed.
Of 46 included studies, the majority of them were conducted with a randomized-controlled (93.5%), single-blind (50.0%), two-arm (84.8%), and parallel (76.1%) design with a 1:1 allocation ratio (95.7%). Through correlation network and heatmap analysis, the moderate-to-very strong correlations between some types of investigational suture materials and primary outcome measures were found including barbed vs non-barbed suture and suturing time, antibacterial-coated vs non-coated suture and wound infection, mono- vs multi-filament suture and wound healing index/markers, and different sizes of suture materials and scar assessment.
Our analysis provides guidance, with several key considerations, for designing a clinical trial evaluating investigational suture materials.
在提交市场批准申请之前，临床试验是任何研究性缝合材料的先决条件。适当的研究设计和主要结局指标是临床试验结果有效性和可靠性的关键。本研究旨在描述研究性缝合材料临床试验中所采用的研究设计和主要结局指标。
在PubMed、EMBASE、Web of Sciences、Scopus和Cochrane数据库中进行系统检索，以收集2019年1月至2021年5月期间发表的相关研究。提取并分析有关一般特征、缝合干预、研究设计和主要结局指标的数据。
在纳入的46项研究中，大多数采用随机对照设计（93.5%）、单盲设计（50.0%）、双臂设计（84.8%）和平行设计（76.1%），分配比例为1:1（95.7%）。通过相关网络和热图分析，发现某些类型的研究性缝合材料与主要结局指标之间存在中度至高度相关性，包括倒刺缝合线与非倒刺缝合线和缝合时间、抗菌涂层缝合线与非涂层缝合线和伤口感染、单丝缝合线与多丝缝合线和伤口愈合指数/标志物，以及不同尺寸的缝合材料与瘢痕评估。
我们的分析为设计评估研究性缝合材料的临床试验提供了指导，并提出了几个关键的注意事项。
