Rapid, Minimally-invasive Voluntary Adult Male Circumcision

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Millard, Simunye Primary Health Care
ClinicalTrials.gov Identifier:
NCT01998360
First received: October 11, 2013
Last updated: February 7, 2014
Last verified: February 2014
Results First Received: November 27, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Circumcision
Interventions: Procedure: Surgical Control
Procedure: Unicirc with 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Unicirc With Tissue Adhesive

Excision of foreskin with Unicirc device and sealing wound with tissue adhesive

Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive

Surgical Control

Surgical circumcision using forceps guided, dorsal slit, or sleeve method

Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.


Participant Flow:   Overall Study
    Unicirc With Tissue Adhesive     Surgical Control  
STARTED     50     50  
COMPLETED     50     50  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
Unicirc With Tissue Adhesive

Excision of foreskin with Unicirc device and sealing wound with tissue adhesive

Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive

Surgical Control

Surgical circumcision using forceps guided, dorsal slit, or sleeve method

Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.

Total Total of all reporting groups

Baseline Measures
    Unicirc With Tissue Adhesive     Surgical Control     Total  
Number of Participants  
[units: participants]
  50     50     100  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     50     50     100  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     50     50     100  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Intraoperative Duration   [ Time Frame: 1 hour ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 1 month ]

3.  Secondary:   Blood Loss   [ Time Frame: During procedure (up to 1 hour) ]

4.  Secondary:   Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks   [ Time Frame: 1 month ]

5.  Secondary:   Cosmetic Result   [ Time Frame: 6 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: 2078663503
e-mail: pmillard@mac.com


No publications provided


Responsible Party: Peter Millard, Simunye Primary Health Care
ClinicalTrials.gov Identifier: NCT01998360     History of Changes
Other Study ID Numbers: Unicirc 002
Study First Received: October 11, 2013
Results First Received: November 27, 2013
Last Updated: February 7, 2014
Health Authority: South Africa: National Health Research Ethics Council