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Durability of Double-gloving With Biogel® Surgical Gloves When Used by Clinicians/Surgeons

NCT03344354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3507

Last updated 2023-08-22

No results posted yet for this study

Summary

A prospective open-label study design was chosen because it will provide the most accurate data on the efficacy of four commercially available similar brands of NRL (natural rubber latex) and synthetic latex surgical gloves when they are used for surgeries in a clinical setting. The primary endpoint will be the overall failure rate of the Biogel® sterile surgical undergloves (device) compared to three undergloves brands of surgical gloves. The secondary endpoints are perforation rates of the underglove, the failure rate of the overglove, the frequency of overglove perforation detection by the glove wearer when double-gloving, the ratio of perforations detected of overglove compared to underglove and to determine the frequency of overglove perforation detection by the glove wearer.

The clinical investigation will be statistically powered to test the hypothesis that the failure rate of the Biogel® Sterile Surgical undergloves is different from that of the three comparators.

Conditions

  • Gloves, Surgical

Interventions

DEVICE

Biogel

Sterile surgical gloves used during surgical procedures.

DEVICE

Ansell

Sterile surgical gloves used during surgical procedures.

DEVICE

Cardinal

Sterile surgical gloves used during surgical procedures.

DEVICE

Medline

Sterile surgical gloves used during surgical procedures.

Sponsors & Collaborators

  • Molnlycke Health Care AB

    lead INDUSTRY

Principal Investigators

  • Michelle Doll, MD, MPH · Virginia Commonwealth University Health

  • Gonzalo M.L. Bearman · Virginia Commonwealth University Health

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2021-11-18
Completion
2022-10-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344354 on ClinicalTrials.gov