Evaluating the Efficacy of 2-Octyl Cyanoacrylate (2-OCA) With Four Interrupted Sutures in Adult Male Circumcision

NCT ID: NCT06487494

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-26
• Study Completion Date: 2025-08-06

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 Men's 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 1:1 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.

Conditions

Phimosis; Paraphimosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2-octyl cyanoacrylate glue with four interrupted sutures

In this arm the provider will use 2-octyl cyanoacrylate glue with four interrupted sutures for wound closing following circumcision.

Group Type: EXPERIMENTAL

Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures

Intervention Type: PROCEDURE

2-octyl cyanoacrylate glue is a wound closure adhesive which will be used with four interrupted sutures following circumcision for wound closure.

Continuous suture

In this arm the provider will use continuous suturing for wound closing following circumcision.

Group Type: ACTIVE_COMPARATOR

Circumcision wound closure using continuous sutuing

Intervention Type: PROCEDURE

Continuous suturing is the standard following circumcision for wound closure.

Interventions

Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures

2-octyl cyanoacrylate glue is a wound closure adhesive which will be used with four interrupted sutures following circumcision for wound closure.

Intervention Type: PROCEDURE

Circumcision wound closure using continuous sutuing

Continuous suturing is the standard following circumcision for wound closure.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients >16 years of age undergoing circumcision will be included.

Exclusion Criteria

• Patients <16 years of age who did not provide consent to be randomized.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Premal Patel, MD

Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Men's Health Clinic Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

HS26545

Identifier Type: -

Identifier Source: org_study_id