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

NCT03344354 | Completed FDA Device

• 1 other identifier: InDure_G016-002
• Study Type: interventional
• Target: 3,507
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Underglove failure rate compared between all competitors

  To determine and compare the failure rate of the Biogel® natural rubber latex (NRL) and synthetic latex study underglove assortment to all competitors combined as non-Biogel.

  Procedures that are scheduled to last a minimum of one (1) hour long

• Underglove failure rate compared to each of the three comparators

  To determine and compare the failure rate of the Biogel® natural rubber latex (NRL) and synthetic latex study underglove assortment to each of the three comparators.

  Procedures that are scheduled to last a minimum of one (1) hour long

Secondary Outcomes (1)

• Underglove perforation rate compared to each of the three comparators comparators separately and combined as non-Biogel.

  Procedures that are scheduled to last a minimum of one (1) hour long

Study Arms (4)

Brand 1

ACTIVE COMPARATOR

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

Device: Biogel

Brand 2

ACTIVE COMPARATOR

sterile surgical gloves

Device: Ansell

Brand 3

ACTIVE COMPARATOR

sterile surgical gloves

Device: Cardinal

Brand 4

ACTIVE COMPARATOR

sterile sergical gloves

Device: Medline

Interventions

Biogel DEVICE

Sterile surgical gloves used during surgical procedures.

Brand 1

Ansell DEVICE

Sterile surgical gloves used during surgical procedures.

Brand 2

Cardinal DEVICE

Sterile surgical gloves used during surgical procedures.

Brand 3

Medline DEVICE

Sterile surgical gloves used during surgical procedures.

Brand 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be certified and licensed physician or a clinician in training under supervision in Orthopedic, Neurosurgery, Cardiothoracic, Colorectal or Trauma specialty surgery services or be working in other OR support functions;
• Directly take part in the surgical procedure work within the sterile field;
• Be willing to wear half size larger underglove if recommended by the manufacturer.
• Perform one of the five target procedure groups which is scheduled to last a minimum of 1 hour;
• Be a current employee or active medical staff member with privileges at the institution conducting the clinical investigation;
• Be willing and able to participate in the written user survey and other tasks associated with the clinical investigation and evaluation of the surgical gloves;
• Be willing and able to read, understand and sign the participant information and consent form prior to the initiation of the clinical investigation.

You may not qualify if:

• Has had or currently has dermatological or other medical conditions that may prevent proper scrub technique and the use of the sterile study surgical gloves for the duration of the participation in the procedure or the span of time the investigation is to take place;
• Wearing of rings, bracelets, or other jewelry that cannot be removed during glove evaluation;
• Incomplete or absent training on the current clinical investigation plan and study participation responsibilities; and
• Is an employee or staff member of the Sponsor, CRO or any other glove manufacturer; or is an immediate relative of an employee of the Sponsor, CRO or any other glove manufacturer.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• Doll M, Namoos A, Kang L, Satpathy J, Feldman MJ, Cassano A, Bohl J, Aboutanos MB, Cameron B, Kim J, Asbury C, Haque M, Hess O, Ahlbom H, Bearman G. A randomized trial comparing the intraoperative durability of double-gloving with Biogel(R) surgical gloves to 3 comparators. Antimicrob Steward Healthc Epidemiol. 2024 Oct 10;4(1):e169. doi: 10.1017/ash.2024.431. eCollection 2024.

  PMID: 39430795 DERIVED

Study Officials

• Michelle Doll, MD, MPH

  Virginia Commonwealth University Health

  PRINCIPAL INVESTIGATOR

• Gonzalo M.L. Bearman

  Virginia Commonwealth University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 17, 2017
• Study Start: April 10, 2018
• Primary Completion: November 18, 2021
• Study Completion: October 26, 2022
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

US (1)