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

March 14, 2014
December 31, 2014
March 2014
September 2014   (final data collection date for primary outcome measure)
Time for Procedure [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Intraoperative time, total
  • Intraoperative bleeding [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Intraoperative bleeding requiring suture
  • Post operative bleeding [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Any bleeding (minor or requiring treatment) that occurs in the first 4 weeks post intervention
Complete list of historical versions of study NCT02091726 on ClinicalTrials.gov Archive Site
  • 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?
  • Infection [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Post-op infection --minor (no treatment), moderate (requires antibiotics)
  • Wound dehiscence [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Wound separation caused by adhesive failure (minor --requires no treatment)
  • Any other adverse event [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Any other adverse event (pain, poor cosmetic result, other intraop or postop complication)
Not Provided
Not Provided
 
Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive
Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Male Circumcision
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
Experimental: Unicirc with tissue adhesive
Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate
Intervention: Procedure: Unicirc instrument plus cyanoacrylate tissue adhesive
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT02091726
Unicirc 003
No
Peter Millard, Simunye Primary Health Care
Simunye Primary Health Care
Not Provided
Study Director: Norman Goldstuck, MD Department of Obstetrics and Gynaecology, Tygerberg Hospital, Cape Town, South Africa
Simunye Primary Health Care
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP