Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive (Unicirc003)

Simunye Primary Health Care

Status: Completed

Conditions: Male Circumcision

Treatments: Procedure: Unicirc instrument plus cyanoacrylate tissue adhesive

Study type: Interventional

Funder types: Other

Identifiers

NCT02091726

Unicirc 003

Details and patient eligibility

About

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

Enrollment: 110 patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Unicirc with tissue adhesive

Experimental group

Description:

Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate

Treatment:

Procedure: Unicirc instrument plus cyanoacrylate tissue adhesive