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NCT03344354 · ClinicalTrials.gov registry record · NA
Durability of Double-gloving With Biogel® Surgical Gloves When Used by Clinicians/Surgeons
A NA study, sponsored by Molnlycke Health Care AB.
- Completed
- Registry status
- NA
- Development phase
- 3,507
- Enrollment target
NCT03344354: Completed NA study, sponsored by Molnlycke Health Care AB.
NCT03344354 is a NA study that has completed, run by Molnlycke Health Care AB. The registered enrollment target is 3,507 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03344354, a NA study, has completed, sponsored by Molnlycke Health Care AB.
- COMPLETED
- Registry status
- NA
- Development phase
- 3,507 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Biogel
- DEVICE Ansell
- DEVICE Cardinal
- DEVICE Medline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,507 participants |
| Start Date | 2018-04-10 |
| Est. Completion | 2022-10-26 |
| Phase | NA |
What the finished NCT03344354 record still lists
NCT03344354 is an interventional study that assigns participants to a tested intervention. Its 3,507 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (150% higher).
The record links to 0 conditions, and to 4 interventions - of which Biogel is the first listed.
NCT03344354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03344354 about?
NCT03344354 is a clinical study titled "Durability of Double-gloving With Biogel® Surgical Gloves When Used by Clinicians/Surgeons". 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...
What is the current status of trial NCT03344354?
This trial is currently completed. It is a NA study. The enrollment target is 3,507 participants. The study started on 2018-04-10. Estimated completion is 2022-10-26.
What interventions are being tested in trial NCT03344354?
The interventions under investigation include: Biogel (DEVICE), Ansell (DEVICE), Cardinal (DEVICE), Medline (DEVICE).
Who is sponsoring clinical trial NCT03344354?
This trial is sponsored by Molnlycke Health Care AB, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03344354's enrollment target sits among peer trials
3,507 36th of 2000 higher than 1,965 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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