Ignite Creation Date:
2024-05-06 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03344354
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2017-11-09
Brief Title:
Durability of Double-gloving With Biogel Surgical Gloves When Used by CliniciansSurgeons
Sponsor:
Molnlycke Health Care AB
Organization:
Molnlycke Health Care AB
Study Overview
Official Title:
InDure A Clinical Investigation Comparing the In-Use Durability of Double-gloving With Biogel Surgical Gloves to Three Comparators
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InDure
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 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
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 ie 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 YN 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
All gloves under evaluation in each phase will be assessed for perforation rate and overall failure on the basis of binomial responses YN 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None