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Completed

NCT Number: NCT02593630

Unicirc Adolescent 12-15 Year Old Boys

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

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Key information

Conditions

Circumcision, Male

Age range

12 year–15 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Simunye Primary Healthcare

Cape Town, Western Cape, South Africa

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy boys desiring circumcision

Exclusion criteria

  • current illness
  • bleeding disorder
  • reaction to local anaesthetic
  • infection
  • any penile abnormality potentially complicating circumcision

Treatment and study plan

Unicirc circumcision

Device

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

Primary outcomes

  1. Intraoperative Duration

    Time frame: Intraoperative, 10-15 minutes

    Duration from placement of instrument to dressing

Secondary outcomes

  1. Intraoperative Pain

    Time frame: 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.

  2. Healed at 4 Weeks

    Time frame: At the 4-week followup visit

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

Sponsors and collaborators

Lead sponsor

Simunye Primary Health Care

Other

Registry information

Official study title

Field Study of Unicirc Circumcision in Adolescent Boys, Aged 12 to 15 Years.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 2, 2015
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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