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

NCT06487494 | Completed

• 1 other identifier: HS26545
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Phimosis; Paraphimosis

Outcome Measures

Primary Outcomes (4)

• Cosmesis

  A cosmetic appearance satisfaction questionnaire will be administered at weeks 6 and 12 post-operation.

  6 and 12 weeks post-operation

• Post-operative Pain

  Using a visual analogue pain scale \[range 0-10; 0 = no pain, 10 = maximal pain\], pain will be assessed as reported by the patient to determine their pain.

  Immediately post-operation and 6 weeks post-operation

• Complication Rate

  Measuring and recording any adverse events post procedure such as surgical site infection, bleeding, hematoma, diffuse swelling, and increased sensitivity amidst intercourse.

  6 and 12 weeks post-operation

• Intra-Operative Time

  Intra-operative time will be measured starting when the physician makes the first incision and ends when sutures are finished.

  During the operation

Study Arms (2)

2-octyl cyanoacrylate glue with four interrupted sutures

EXPERIMENTAL

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

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

Continuous suture

ACTIVE COMPARATOR

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

Procedure: Circumcision wound closure using continuous sutuing

Interventions

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

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

2-octyl cyanoacrylate glue with four interrupted sutures

Circumcision wound closure using continuous sutuing PROCEDURE

Continuous suturing is the standard following circumcision for wound closure.

Continuous suture

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Men's Health Clinic Manitoba

Winnipeg, Manitoba, R3K 1M3, Canada

Location

MeSH Terms

Conditions

Phimosis; Paraphimosis

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Surgery. Director, Undergraduate Urologic Medical Education

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: August 26, 2024
• Primary Completion: August 6, 2025
• Study Completion: August 6, 2025
• Last Updated: September 5, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)