Unicirc vs Open Surgical Circumcision

Phase 4

Completed

• Conditions: Circumcision, Male
• Interventions: Procedure: Unicirc with tissue adhesive; Procedure: Open Surgical

• Registration Number: NCT02443792
• Lead Sponsor: Simunye Primary Health Care

Brief Summary

RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-14
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2015-10-29
• Results First Submitted QC: 2015-12-13
• Results First Posted: 2016-01-20
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 75

Inclusion Criteria

• Healthy male
• Uncircumcised
• With normal penile anatomy

Exclusion Criteria

• Concurrent illness
• History of bleeding disorder
• Past reaction to local anesthetic
• Infection
• Penile abnormality which could complicate circumcision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unicirc with tissue adhesive	Unicirc with tissue adhesive	Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Open Surgical	Open Surgical	Open surgical circumcision under local anesthetic with suturing

Primary Outcome Measures

Name	Time	Method
Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing	Up to 30 minutes	Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing

Secondary Outcome Measures

Name	Time	Method
Surgical Pain 0=no Pain; 10=Worst Pain Ever	Up to 30 minutes	Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever
Completely Healed at 4 Weeks	At the 4-week followup visit	Number of participants who were completely healed at 4 weeks
Wound Dehiscence	Up to 4 weeks	Proportion experiencing wound dehiscence (\< 2 cm vs \> 2 cm)
Infection	Up to 4 weeks	Proportion experiencing post-op infection, determined clinically (treated with antibiotics)

Trial Locations

Locations (1)

Lonmin Hospital; 🇿🇦 Marikana, Northwest, South Africa