Status:
COMPLETED
Durability of Double-gloving With Biogel® Surgical Gloves When Used by Clinicians/Surgeons
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Gloves, Surgical
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 syntheti...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2022
Estimated Enrollment :
3507 Patients enrolled
Trial Details
Trial ID
NCT03344354
Start Date
April 10 2018
End Date
October 26 2022
Last Update
August 22 2023
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298