1. A randomized trial comparing the intraoperative durability of double-gloving with Biogel® surgical gloves to 3 comparators
- Author
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Michelle Doll, Asmaa Namoos, Le Kang, Jibanananda Satpathy, Michael J. Feldman, Anthony Cassano, Jaime Bohl, Michel B. Aboutanos, Brian Cameron, Jason Kim, Celine Asbury, Mahdee Haque, Olivia Hess, Henrik Ahlbom, and Gonzalo Bearman
- Subjects
Infectious and parasitic diseases ,RC109-216 ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Objective: To determine and compare the intraoperative durability of 4 major surgical glove brands. Design, Setting, and Participants: This study is a randomized open-label clinical trial in which surgical gloves from 4 manufacturers are randomized to 5 surgical subspecialty study groups: (1) orthopedic surgery, (2) neurosurgery, (3) colorectal surgery, (4) trauma or acute general surgery, and (5) cardiac and plastic surgeries. The study was divided into 10 periods, with a cross-over design, and was conducted at a tertiary care academic medical center. Participants were licensed and certified physicians, physicians-in-training, scrub nurses, or technicians working within the sterile field. Interventions: Participants from each study group were randomly assigned to 1 of 4 surgical glove manufacturer types and subsequently rotated through the other 3 glove brands such that each participant acted as their own control in the sequential cross-over design. Main Outcomes and Measures: The primary outcome was to determine and compare the intraoperative failure rate of Biogel® Sterile Surgical undergloves against sterile surgical undergloves from 3 other manufacturers, both as a combined competitor group and individually. Results: There were no differences between brands with respect to the primary outcome of underglove intraoperative failures. Brand 1 wearers were slightly more likely to detect glove failures when they occurred. Conclusion: The durability of surgical gloves intraoperatively is similar across 4 major glove manufacturers. Detection of intraoperative failures is infrequent, though specific glove characteristics may promote enhanced detection. Recognition of glove perforations intraoperatively is important in the maintenance of a maximally sterile field. Trial Registration: ClinicalTrials.gov Identifier: NCT03344354.
- Published
- 2024
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