Background: 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.
Methods: 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.
Results: 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.
Conclusions: Our analysis provides guidance, with several key considerations, for designing a clinical trial evaluating investigational suture materials.
Keywords: Sutures; clinical trial; medical device; research design; suture material.