A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision

NCT01877408 | Completed Results

• 1 other identifier: UNICIRC SA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To identify a minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.

Conditions

Circumcision

Keywords

disposable circumcision device; Tissue adhesive; Open surgical circumcision; Minimally-invasive circumcision

Outcome Measures

Primary Outcomes (1)

• Intraoperative Duration

  Amount of time from first manipulation of tissue under local anesthesia to dressing

  1 hour

Secondary Outcomes (5)

• Difficulty in Learning and Performing Technique

  1 year

• Number of Participants With Complete Wound Healing by Post-Surgery Week 4

  Within 4 weeks after surgery

• Pain Experienced

  Within 2 days after surgery

• Overall Patient Satisfaction

  Within 6 weeks after surgery

• Cosmetic Result

  Within 6 weeks after surgery

Other Outcomes (1)

• Number of Participants With Adverse Events

  1 year

Study Arms (2)

Open surgical circumcision

ACTIVE COMPARATOR

The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.

Procedure: Open surgical circumcision

Unicirc device with tissue adhesive

EXPERIMENTAL

Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.

Device: Unicirc device with tissue adhesive

Interventions

Open surgical circumcision PROCEDURE

Open surgical circumcision using a technique approved by the WHO (dorsal slit)

Open surgical circumcision

Unicirc device with tissue adhesive DEVICE

Removal of foreskin with Unicirc disposal device and wound sealing with tissue adhesive.

Unicirc device with tissue adhesive

Eligibility Criteria

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

You may qualify if:

• Healthy men at least 18 years of age requesting circumcision
• No anatomical penile abnormalities or infections
• Able to provide informed consent to participate
• Willing to participate in follow-up visits

You may not qualify if:

• Current illness
• Penile abnormality or infection which contraindicates or would complicate circumcision
• History of bleeding disorder
• Past reaction to local anesthetic

Sponsors & Collaborators

• Simunye Primary Health Care: lead

Study Sites (1)

Simunye Primary Healthcare

Mitchells Plain, Western Cape, South Africa

Location

MeSH Terms

Interventions

Tissue Adhesives

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Peter Millard
• Organization: University of New England

pmillard@mac.com

2078663503

Study Officials

• Peter S Millard, MD, PhD

  Simunye Primary Health Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: PI

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 13, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 2, 2018
• Results First Posted: February 6, 2014

Record last verified: 2018-09

Locations

ZA (1)