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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01998360
Other study ID # Unicirc 002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date October 2013

Study information

Verified date September 2018
Source Simunye Primary Health Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate a new, minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
South Africa Simunye Primary Healthcare Mitchells Plain Western Cape

Sponsors (1)

Lead Sponsor Collaborator
Simunye Primary Health Care

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative Duration The number of minutes required to perform the surgical procedure 1 hour
Secondary Number of Participants With Adverse Events Bleeding, hematoma, infection and other rare adverse events 1 month
Secondary Blood Loss Number of ml of blood lost during the procedure, as assessed by the surgeon During procedure (up to 1 hour)
Secondary Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks The number of participants with complete epithelialization (completely healed) at 4 weeks 1 month
Secondary Cosmetic Result Regular: scar line straight without any irregularity
Irregular: Some irregularity to scar line
Scalloped: wavy appearane to scar line
6 weeks
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