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
Results First Received: December 1, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Male Circumcision
Intervention: Procedure: Unicirc instrument plus cyanoacrylate tissue adhesive

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Three generalist physicians (GPs) performed the circumcisions in individual consultation rooms in their own primary health care clinic.

The study took place between January 20 and July 4, 2014.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Unicirc With Tissue Adhesive

Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate

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


Participant Flow:   Overall Study
    Unicirc With Tissue Adhesive  
STARTED     110  
1 Week Followup     110  
4 Week Followup     104  
COMPLETED     104  
NOT COMPLETED     6  
Lost to Follow-up                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Volunteers

Reporting Groups
  Description
Unicirc With Tissue Adhesive

Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate

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


Baseline Measures
    Unicirc With Tissue Adhesive  
Number of Participants  
[units: participants]
  110  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     110  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     110  
Region of Enrollment  
[units: participants]
 
South Africa     110  



  Outcome Measures
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1.  Primary:   Time for Procedure   [ Time Frame: 1 hour ]

2.  Secondary:   Completely Healed at 4 Weeks   [ Time Frame: 4 weeks ]

3.  Secondary:   Wound Separation   [ Time Frame: 4 weeks ]

4.  Secondary:   Cosmetic Result Excellent   [ Time Frame: 4 weeks ]

5.  Secondary:   Participant Fully Satisfied and Would Recommend to Friends and Family   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter S. Millard, MD, PhD
Organization: University of New England
phone: 2072992131
e-mail: pmillard@mac.com


No publications provided


Responsible Party: Peter Millard, 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