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

NCT01877408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-10-02

Study results available
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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

Interventions

PROCEDURE

Open surgical circumcision

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

DEVICE

Unicirc device with tissue adhesive

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

Sponsors & Collaborators

  • Simunye Primary Health Care

    lead OTHER

Principal Investigators

  • Peter S Millard, MD, PhD · Simunye Primary Health Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01877408 on ClinicalTrials.gov