Unicirc Adolescent 12-15 Year Old Boys
Phase 4
Completed
- Conditions
- Circumcision, Male
- Interventions
- Device: Unicirc circumcision
- Registration Number
- NCT02593630
- Lead Sponsor
- Simunye Primary Health Care
- Brief Summary
This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.
- Detailed Description
Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 54
Inclusion Criteria
- healthy boys desiring circumcision
Exclusion Criteria
- current illness
- bleeding disorder
- reaction to local anaesthetic
- infection
- any penile abnormality potentially complicating circumcision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Unicirc circumcision Unicirc circumcision Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive
- Primary Outcome Measures
Name Time Method Intraoperative Duration Intraoperative, 10-15 minutes Duration from placement of instrument to dressing
- Secondary Outcome Measures
Name Time Method Intraoperative Pain Time of surgery, approximately 10-15 minutes Intraoperative pain, measured on a standard 10 point pain scale (0=no pain, 5=moderate pain, 10 severe pain) using a pain face diagram.
Healed at 4 Weeks At the 4-week followup visit Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks.
Trial Locations
- Locations (1)
Simunye Primary Healthcare
🇿🇦Cape Town, Western Cape, South Africa