Analysis of study designs and primary outcome measures in clinical trials of investigational suture materials

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.

KEYWORDS:

• Sutures
• suture material
• medical device
• clinical trial
• research design

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

Additional information

Funding

This research work was supported by the Program Management Unit for Enhancement of the Country’s Competitiveness (PMU-C), under the Office of National Higher Education Science Research and Innovation Policy Council (NXPO) (Grant number: C10F630148), and partially supported by Chiang Mai University.