Unicirc vs Open Surgical Circumcision (Unicirc004)

September 5, 2018 updated by: Justin Shenje, MB ChB, Simunye Primary Health Care

Adult Male Circumcision With Unicirc Under Topical Anesthetic vs Open Surgical Circumcision: a Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Northwest
      • Marikana, Northwest, South Africa
        • Lonmin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unicirc with tissue adhesive
Unicirc under topical anesthetic w/ cyanoacrylate wound sealing
Procedure: Unicirc with tissue adhesive
As above
Active Comparator: Open Surgical
Open surgical circumcision under local anesthetic with suturing
Procedure: Open Surgical
As above

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Simunye Primary Health Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 10, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Unicirc004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Circumcision, Male

Clinical Trials on Unicirc with tissue adhesive

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe