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

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ClinicalTrials.gov Identifier: NCT02091726
Recruitment Status : Completed
First Posted : March 19, 2014
Results First Posted : December 11, 2014
Last Update Posted : December 14, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a field trial of the Unicirc instrument to excise the foreskin, plus use of cyanoacrylate tissue adhesive to seal the wound.

Condition or disease Intervention/treatment
Male Circumcision Procedure: Unicirc instrument plus cyanoacrylate tissue adhesive

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
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
Study Start Date : March 2014
Primary Completion Date : September 2014
Study Completion Date : September 2014
Arms and Interventions

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

Outcome Measures

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

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

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

  3. 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. 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?

Eligibility Criteria

Information from the National Library of Medicine

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

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

South Africa
Simunye Primary Healthcare
Cape Town, Western Cape, South Africa
Sponsors and Collaborators
Simunye Primary Health Care
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 Posted: March 19, 2014    Key Record Dates
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:
HIV prevention
Surgical device
Tissue Adhesive