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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02091726
First Posted: March 19, 2014
Last Update Posted: December 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Millard, Simunye Primary Health Care
  Purpose
This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.

Condition Intervention
Male Circumcision Procedure: Unicirc instrument plus cyanoacrylate tissue adhesive

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive

Further study details as provided by Peter Millard, Simunye Primary Health Care:

Primary Outcome Measures:
  • Time for Procedure [ Time Frame: 1 hour ]
    Intraoperative time, total


Secondary Outcome Measures:
  • Completely Healed at 4 Weeks [ Time Frame: 4 weeks ]
    Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present

  • Wound Separation [ Time Frame: 4 weeks ]
    Wound separation caused by adhesive failure (minor --requires no treatment)

  • 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

  • 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?


Enrollment: 110
Study Start Date: March 2014
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02091726


Locations
South Africa
Simunye Primary Healthcare
Cape Town, Western Cape, South Africa
Sponsors and Collaborators
Simunye Primary Health Care
Investigators
Study Director: Norman Goldstuck, MD Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, South Africa
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Millard, PI, Simunye Primary Health Care
ClinicalTrials.gov Identifier: NCT02091726     History of Changes
Other Study ID Numbers: Unicirc 003
First Submitted: March 14, 2014
First Posted: March 19, 2014
Results First Submitted: December 1, 2014
Results First Posted: December 11, 2014
Last Update Posted: December 14, 2015
Last Verified: November 2015

Keywords provided by Peter Millard, Simunye Primary Health Care:
Circumcision
HIV prevention
Surgical device
Cyanoacrylate
Tissue Adhesive
voluntary