Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive

Male Circumcision Clinical Trial

— Unicirc003  

Official title:

Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091726
• Other study ID #: Unicirc 003
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 2014

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Male Circumcision

Intervention

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

Locations

Country	Name	City	State
South Africa	Simunye Primary Healthcare	Cape Town	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	Time for Procedure	Intraoperative time, total	1 hour
Secondary	Completely Healed at 4 Weeks	Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present	4 weeks
Secondary	Wound Separation	Wound separation caused by adhesive failure (minor --requires no treatment)	4 weeks
Secondary	Cosmetic Result Excellent	Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line	4 weeks
Secondary	Participant Fully Satisfied and Would Recommend to Friends and Family	Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family?	4 weeks