Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06487494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
Evaluating the Efficacy of 2-Octyl Cyanoacrylate 2-OCA With Four Interrupted Sutures in Adult Male Circumcision
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Is 2-Octyl Cyanoacrylate 2-OCA With Four Interrupted Sutures Non-inferior to Continuous Suturing as a Wound Closure Technique in Adult Male Circumcision A Randomized Controlled Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This study aims to determine whether cyanoacrylate glue is a non-inferior alternative to continuous suturing for wound closure following adult circumcision The primary objective of this study is to evaluate and compare operative time pain cosmesis complications and patient satisfaction associated with the use of cyanoacrylate glue versus standard suturing for wound closure To the best of our knowledge this will be one of the first studies to investigate the use of cyanoacrylate glue for wound closure following adult circumcision The findings from this study could provide valuable insights into the potential benefits of using cyanoacrylate glue as a non-inferior alternative to continuous suturing for wound closure Additionally this study may also inform clinical practice guidelines on the most effective techniques for wound closure following adult circumcision
Detailed Description:
This non-blinded randomized controlled pilot study is to be conducted at the Mens Health Clinic in Winnipeg Manitoba All eligible patients undergoing circumcision will be invited to participate in the study They will be randomly assigned in a 11 ratio using a computer-generated random list Patients will be randomized to 2-Octyl cyanoacrylate 2-OCA with four interrupted sutures vs standard suturing alone In the post-operative recovery area patients will be asked to complete a VAS questionnaire Patients will then be brought in for their routine visit 6 weeks post-op During the visit closure of the wound as well as any potential complications will be assessed by a research team member At that time a questionnaire will be administered to study participants to assess variables such as post-procedure pain as well as their satisfaction with the recovery process and cosmesis post-circumcision Cosmesis and complications will also be assessed 12 weeks post-op
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None