NCT03344354 (InDure) is a NA clinical trial of Biogel in Gloves, Surgical, sponsored by Molnlycke Health Care AB.

Who is sponsoring NCT03344354?

NCT03344354 is sponsored by Molnlycke Health Care AB.

What drugs are being tested in NCT03344354?

Interventions in NCT03344354: Biogel, Ansell, Cardinal, Medline.

What condition does NCT03344354 study?

NCT03344354 studies Gloves, Surgical.

Is NCT03344354 still recruiting?

NCT03344354 is currently completed. Last updated 22 August 2023.

Last reviewed 2023-08-22 · How we verify

NCT03344354: InDure

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 22 August 2023

What this trial tests

NA trial testing Biogel in Gloves, Surgical in 3,507 participants. Completed in 26 October 2022.

Timeline

10 April 2018

Primary endpoint
18 November 2021

26 October 2022

Quick facts

Lead sponsor	Molnlycke Health Care AB
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	3,507
Start date	10 April 2018
Primary completion	18 November 2021
Estimated completion	26 October 2022
Sites	1 location across United States

Drugs / interventions tested

Biogel
Ansell
Cardinal
Medline

Conditions studied

Gloves, Surgical — all drugs for Gloves, Surgical →

Sponsor

Molnlycke Health Care AB — full company profile →

Who can join

18 and older, any sex, with Gloves, Surgical. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A randomized trial comparing the intraoperative durability of double-gloving with Biogel® surgical gloves to 3 comparators.
Doll M, Namoos A, Kang L, Satpathy J, et al · · 2024 · PMID 39430795 · DOI 10.1017/ash.2024.431

Verify or expand the search:

Other Molnlycke Health Care AB trials

Trials by the same sponsor.

NCT06661473 — Interventional Study Exploring the Occurrence of Surgical Site Infections. · NA · completed
NCT06321978 — Mepilex Border Flex Utilization Pilot Spain · recruiting
NCT05608317 — A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing · NA · recruiting
NCT05494450 — An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fi · NA · terminated
NCT04960553 — A PMCF Investigation on Exuding Chronic Wounds Using Exufiber® as Primary Dressing, and Mepilex® Border Flex/Comfort · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03344354 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Molnlycke Health Care AB
Last refreshed: 22 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03344354.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing