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Completed

NCT Number: NCT06487494

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

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.

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Key information

Conditions

Phimosis Genital Diseases Genital Diseases, Male Male Urogenital Diseases Paraphimosis Penile Diseases Urogenital Diseases

Age range

16 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Men's Health Clinic Manitoba

Winnipeg, Manitoba, R3K 1M3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Circumcision wound closure using continuous sutuing

Procedure

Continuous suturing is the standard following circumcision for wound closure.

Primary outcomes

  1. Cosmesis

    Time frame: 6 and 12 weeks post-operation

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

  2. Post-operative Pain

    Time frame: Immediately post-operation and 6 weeks post-operation

    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.

  3. Complication Rate

    Time frame: 6 and 12 weeks post-operation

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

  4. Intra-Operative Time

    Time frame: During the operation

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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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