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OpenTrials
Completed

NCT Number: NCT02091726

Phase 4 Field Trial of the Unicirc Instrument With Tissue Adhesive

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

Completed

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Key information

Conditions

Male Circumcision

Age range

18 year–99 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Simunye Primary Healthcare

Cape Town, Western Cape, South Africa

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Unicirc instrument plus cyanoacrylate tissue adhesive

Procedure

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

Other names: Unicirc, Cyanoacrylate

Primary outcomes

  1. Time for Procedure

    Time frame: 1 hour

    Intraoperative time, total

Secondary outcomes

  1. Completely Healed at 4 Weeks

    Time frame: 4 weeks

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

  2. Wound Separation

    Time frame: 4 weeks

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

  3. Cosmetic Result Excellent

    Time frame: 4 weeks

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

  4. Participant Fully Satisfied and Would Recommend to Friends and Family

    Time frame: 4 weeks

    Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family?

Sponsors and collaborators

Lead sponsor

Simunye Primary Health Care

Other

Registry information

Acronym: Unicirc003

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 19, 2014
Registry last updated
Sep 6, 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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