An interventional study of Biogel and Ansell in Gloves, Surgical, sponsored by Molnlycke Health Care AB. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Molnlycke Health Care AB · Not applicable, Interventional, and Other
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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.
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:
No patients have been enrolled in this study therefore no patient data will be assessed.
Molnlycke Health Care AB is the lead sponsor of 59 studies on the registry; 8 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
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All study clinicians, i.e. study glove wearers, must meet all of the following Inclusion Criteria in order to be included in the investigation:
Exclusion Criteria:
All potential study participants who meets any of the following Exclusion Criteria will not be included in the investigation:
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
Device: Ansell
sterile surgical gloves
Device: Cardinal
sterile sergical gloves
Device: Medline
Sterile surgical gloves used during surgical procedures.
Sterile surgical gloves used during surgical procedures.
Sterile surgical gloves used during surgical procedures.
Sterile surgical gloves used during surgical procedures.
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.
Time frame: 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.
Time frame: Procedures that are scheduled to last a minimum of one (1) hour long
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.
Time frame: Procedures that are scheduled to last a minimum of one (1) hour long
Ran from Apr 2018 to primary completion in Nov 2021, 43 months.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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