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OpenTrials
Completed

NCT Number: NCT02443792

Unicirc vs Open Surgical Circumcision

RCT of Unicirc under topical anesthetic w/ cyanoacrylate wound sealing vs. open surgical circumcision under local anesthetic with suturing.

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Key information

Conditions

Circumcision, Male

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Lonmin Hospital

Marikana, Northwest, South Africa

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male
  • Uncircumcised
  • With normal penile anatomy

Exclusion criteria

  • Concurrent illness
  • History of bleeding disorder
  • Past reaction to local anesthetic
  • Infection
  • Penile abnormality which could complicate circumcision

Treatment and study plan

Unicirc with tissue adhesive

Procedure

As above

Open Surgical

Procedure

As above

Primary outcomes

  1. Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing

    Time frame: Up to 30 minutes

    Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing

Secondary outcomes

  1. Surgical Pain 0=no Pain; 10=Worst Pain Ever

    Time frame: Up to 30 minutes

    Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever

  2. Completely Healed at 4 Weeks

    Time frame: At the 4-week followup visit

    Number of participants who were completely healed at 4 weeks

  3. Wound Dehiscence

    Time frame: Up to 4 weeks

    Proportion experiencing wound dehiscence (< 2 cm vs > 2 cm)

  4. Infection

    Time frame: Up to 4 weeks

    Proportion experiencing post-op infection, determined clinically (treated with antibiotics)

Sponsors and collaborators

Lead sponsor

Simunye Primary Health Care

Other

Registry information

Official study title

Adult Male Circumcision With Unicirc Under Topical Anesthetic vs Open Surgical Circumcision: a Randomized Controlled Trial

Acronym: Unicirc004

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 14, 2015
Registry last updated
Oct 3, 2018

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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