Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Our analysis provides guidance, with several key considerations, for designing a clinical trial evaluating investigational suture materials.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Our analysis provides guidance, with several key considerations, for designing a clinical trial evaluating investigational suture materials.
摘要：
未经批准：临床试验是市场批准申请前任何研究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。本研究旨在描述在研究性缝合材料的临床试验中应用的研究设计和主要结果指标。
UNASSIGNED：PubMed上的系统搜索，EMBASE,WebofSciences,Scopus,和Cochrane数据库进行收集2019年1月至2021年5月发表的相关研究。一般特性数据，缝合介入,研究设计，提取并分析主要结局指标。
未经批准：在纳入的46项研究中，其中大多数是用随机对照(93.5%)进行的，单盲（50.0%），双臂(84.8%)，和平行(76.1%)设计，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非常强的相关性，包括倒刺与无倒刺缝合和缝合时间，抗菌涂层与无涂层缝合线和伤口感染，单丝与复丝缝合和伤口愈合指数/标记，以及不同尺寸的缝合材料和疤痕评估。
未经评估：我们的分析提供了指导，有几个关键的考虑因素，用于设计一项评估研究性缝合材料的临床试验。
UNASSIGNED：PubMed上的系统搜索，EMBASE,WebofSciences,Scopus,和Cochrane数据库进行收集2019年1月至2021年5月发表的相关研究。一般特性数据，缝合介入,研究设计，提取并分析主要结局指标。
未经批准：在纳入的46项研究中，其中大多数是用随机对照(93.5%)进行的，单盲（50.0%），双臂(84.8%)，和平行(76.1%)设计，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非常强的相关性，包括倒刺与无倒刺缝合和缝合时间，抗菌涂层与无涂层缝合线和伤口感染，单丝与复丝缝合和伤口愈合指数/标记，以及不同尺寸的缝合材料和疤痕评估。
未经评估：我们的分析提供了指导，有几个关键的考虑因素，用于设计一项评估研究性缝合材料的临床试验。
