Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive (Unicirc003)

September 4, 2018 updated by: Peter Millard, Simunye Primary Health Care
This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

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
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • Simunye Primary Healthcare

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men at least 18 years of age

Exclusion Criteria:

  • Poor general health
  • Anatomical abnormalities that would complicate circumcision
  • Bleeding disorder
  • Ongoing infection
  • Cannot attend followup visits

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unicirc with tissue adhesive
Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Procedure: Unicirc instrument plus cyanoacrylate tissue adhesive
Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
Other Names:
  • Unicirc
  • Cyanoacrylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for Procedure
Time Frame: 1 hour
Intraoperative time, total
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completely Healed at 4 Weeks
Time Frame: 4 weeks
Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present
4 weeks
Wound Separation
Time Frame: 4 weeks
Wound separation caused by adhesive failure (minor --requires no treatment)
4 weeks
Cosmetic Result Excellent
Time Frame: 4 weeks
Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line
4 weeks
Participant Fully Satisfied and Would Recommend to Friends and Family
Time Frame: 4 weeks
Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family?
4 weeks

Collaborators and Investigators

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

Sponsor

Simunye Primary Health Care

Investigators

  • Study Director: Norman Goldstuck, MD, Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, South Africa

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

March 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 19, 2014

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Unicirc 003

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.

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