Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive

N/ACompletedNCT02091726

Simunye Primary Health Care110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

110

Conditions

Male Circumcision

Interventions

Unicirc instrument plus cyanoacrylate tissue adhesivePROCEDURE

Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive

Eligibility

Sex: MALEMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Simunye Primary Healthcare

Cape Town, Western Cape, South Africa

Outcomes

Primary Outcomes

Time for Procedure

Intraoperative time, total

Time frame: 1 hour

Secondary Outcomes

Completely Healed at 4 Weeks

Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present

Time frame: 4 weeks

Wound Separation

Wound separation caused by adhesive failure (minor --requires no treatment)

Time frame: 4 weeks

Cosmetic Result Excellent

Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line

Time frame: 4 weeks

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?

Time frame: 4 weeks

Data from ClinicalTrials.gov

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