Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Millard, Simunye Primary Health Care
ClinicalTrials.gov Identifier:
NCT02091726
First received: March 14, 2014
Last updated: December 31, 2014
Last verified: December 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive

Further study details as provided by Simunye Primary Health Care:

Primary Outcome Measures:
  • Time for Procedure [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Intraoperative time, total


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

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

  • Cosmetic Result Excellent [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Peter Millard, PI, Simunye Primary Health Care
ClinicalTrials.gov Identifier: NCT02091726     History of Changes
Other Study ID Numbers: Unicirc 003
Study First Received: March 14, 2014
Results First Received: December 1, 2014
Last Updated: December 31, 2014
Health Authority: South Africa: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on March 03, 2015