ABSTRACT
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.
Article highlights
The appropriate study designs and primary outcome measures are key to the validity and reliability of clinical trial results.
A randomized-controlled, single-blind, two-arm, parallel design with an equal allocation ratio is the most common study design applied in investigational suture materials trials.
Determination of primary outcome measures in investigational suture material trials is mainly correlated with the type of investigational suture materials.
The maximum follow-up duration required for each primary outcome measure depends to a large degree on the pathophysiology of the outcome and/or well-accepted standard guidelines/recommendations.
When deciding on trial design types, it is also important to consider the types of surgeries and characteristics of the disease.
Author contributions
NK, DP, and WP originated the study conception; ND, NK, and MN designed the study protocol; ND and WS collected relevant articles and extracted the data; ND, WS, NK, and MN analyzed the data, and all authors interpreted the results; ND and NK wrote the manuscript, with contributions from all authors.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants, or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Supplemental material
Supplemental data for this article can be accessed here