Unicirc Adolescent 12-15 Year Old Boys

Simunye Primary Health Care54 enrolled

Overview

This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.

Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Circumcision, Male

Interventions

Unicirc circumcisionDEVICE

Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive

Eligibility

Sex: MALEMin age: 12 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy boys desiring circumcision Exclusion Criteria: * current illness * bleeding disorder * reaction to local anaesthetic * infection * any penile abnormality potentially complicating circumcision

Locations (1)

Simunye Primary Healthcare

Cape Town, Western Cape, South Africa

Outcomes

Primary Outcomes

Intraoperative Duration

Duration from placement of instrument to dressing

Time frame: Intraoperative, 10-15 minutes

Secondary Outcomes

Intraoperative Pain

Intraoperative pain, measured on a standard 10 point pain scale (0=no pain, 5=moderate pain, 10 severe pain) using a pain face diagram.

Time frame: Time of surgery, approximately 10-15 minutes

Healed at 4 Weeks

Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks.

Time frame: At the 4-week followup visit

Data from ClinicalTrials.gov

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