Unicirc Adolescent 12-15 Year Old Boys

January 31, 2019 updated by: Peter Millard, Simunye Primary Health Care

Field Study of Unicirc Circumcision in Adolescent Boys, Aged 12 to 15 Years.

This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.

Study Type

Interventional

Enrollment (Actual)

54

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
    • 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

12 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy boys desiring circumcision

Exclusion Criteria:

  • current illness
  • bleeding disorder
  • reaction to local anaesthetic
  • infection
  • any penile abnormality potentially complicating 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unicirc circumcision
Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive
Device: Unicirc circumcision
Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Duration
Time Frame: Intraoperative, 10-15 minutes
Duration from placement of instrument to dressing
Intraoperative, 10-15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Pain
Time Frame: Time of surgery, approximately 10-15 minutes
Intraoperative pain, measured on a standard 10 point pain scale (0=no pain, 5=moderate pain, 10 severe pain) using a pain face diagram.
Time of surgery, approximately 10-15 minutes
Healed at 4 Weeks
Time Frame: At the 4-week followup visit
Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks.
At the 4-week followup visit

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, University of Stellenbosch

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 (Actual)

April 1, 2016

Primary Completion (Actual)

November 15, 2016

Study Completion (Actual)

November 15, 2016

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

November 1, 2015

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Unicirc Adolescent

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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