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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-10

Study Completion Date

2022-10-26

Brief Summary

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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.

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Detailed Description

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This is a non-significant risk, cross-over, comparative, prospective, five-armed, open-label clinical investigation in which the perforation rate of surgical gloves from four different manufacturers will be evaluated in double-gloving fashion. Study clinicians who will directly in the sterile field, with a similar surgical procedural work scope will be asked to use gloves from the four manufacturers of surgical gloves while performing surgical procedures. The types of procedures under which the study gloves will be put in use are prosthetic joints arthroplasty and implantation (i.e. orthopedic), trauma surgery, neurosurgery, colorectal and cardiothoracic surgery.

All gloves under evaluation in each phase will be assessed for perforation rate and overall failure on the basis of binomial responses (Y/N) looking at five time points:

* glove failure pre-donning (after removal from pack, prior to donning)
* glove failure during donning (putting the gloves on)
* observed intraoperative glove failure
* glove failure during doffing (glove removal)
* post-procedure: glove perforation and failure determined using a standardized water leak test

No patients have been enrolled in this study therefore no patient data will be assessed.

Conditions

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Gloves, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a non-significant risk, crossover, comparative, prospective, five-armed, open-label clinical investigation in which failure rates of surgical gloves from four manufacturers will be evaluated in double-gloving fashion.

The investigation is to be conducted over the course of ten (10) periods where the Biogel® brand of NRL and synthetic latex overgloves and undergloves are compared to other brand products from three manufacturers with comparable glove materials and thickness, and used during similar types of procedures. Study clinicians will be divided into five study groups based on specialty: Cardiothoracic and plastic surgery, Neurosurgery, Orthopaedic surgery, Trauma and acute general surgery, and Colorectal surgery. Before the first period each of five study groups will be randomized to one glove brand to start with in period 1. After each period the study group will cross over to the next period and brand of gloves according to a pre-defined order of rotation.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Brand 1

sterile surgical gloves Two arms of Brand 1 were combined to allow comparison of the total of all comparator gloves.

Group Type ACTIVE_COMPARATOR