NCT03344354

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,507 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Gloves, Surgical

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-04-10
• Primary completion: 2021-11-18
• Completion: 2022-10-26
• First posted: 2017-11-17
• Last updated: 2023-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study