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

InDure: A Clinical Investigation Comparing the In-Use Durability of Double-gloving With Biogel® Surgical Gloves to Three Comparators

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.

Study Overview

• Status: Completed
• Conditions: Gloves, Surgical
• Intervention / Treatment: Device: Biogel; Device: Ansell; Device: Cardinal; Device: Medline

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 3507
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Pham; Phone Number: +46 31 722 30 00; Email: david.pham@molnlycke.com

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All study clinicians, i.e. study glove wearers, must meet all of the following Inclusion Criteria in order to be included in the investigation:

• 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.

Exclusion Criteria:

All potential study participants who meets any of the following Exclusion Criteria will not be included in the investigation:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brand 1; sterile surgical gloves Two arms of Brand 1 were combined to allow comparison of the total of all comparator gloves.	Device: Biogel; Sterile surgical gloves used during surgical procedures.
Active Comparator: Brand 2; sterile surgical gloves	Device: Ansell; Sterile surgical gloves used during surgical procedures.
Active Comparator: Brand 3; sterile surgical gloves	Device: Cardinal; Sterile surgical gloves used during surgical procedures.
Active Comparator: Brand 4; sterile sergical gloves	Device: Medline; Sterile surgical gloves used during surgical procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Underglove perforation rate compared to each of the three comparators comparators separately and combined as non-Biogel.	To determine and compare the perforation rate of the Biogel® NRL and synthetic latex study underglove assortment to that of the three comparators separately and combined as non-Biogel.	Procedures that are scheduled to last a minimum of one (1) hour long

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Michelle Doll, MD, MPH, Virginia Commonwealth University Health; Principal Investigator: Gonzalo M.L. Bearman, Virginia Commonwealth University Health

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2018
• Primary Completion (Actual): November 18, 2021
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: InDure_G016-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No