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

University of Manitoba

Status: Completed

Conditions: Phimosis; Paraphimosis

Treatments: Procedure: Circumcision wound closure using 2-octyl cyanoacrylate glue with four interrupted sutures; Procedure: Circumcision wound closure using continuous sutuing

Study type: Interventional

Funder types: Other

Identifiers

NCT06487494

HS26545

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 16 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

2-octyl cyanoacrylate glue with four interrupted sutures

Experimental group

Description:

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

Treatment:

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

Continuous suture

Active Comparator group

Description:

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

Treatment:

Procedure: Circumcision wound closure using continuous sutuing