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Completed

NCT Number: NCT01794221

The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision

The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.

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Key information

Conditions

Phimosis Adhesions Cicatrix Fibrosis Genital Diseases Genital Diseases, Male Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Penile Diseases Tissue Adhesions Urogenital Diseases

Age range

1 day–7 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.

Secondary Objective(s) To assess parent satisfaction and comfort level after circumcision with use of 2-octyl cyanoacrylate skin adhesive and compare to those undergoing circumcision without the use of 2-octyl cyanoacrylate skin adhesive.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients undergoing circumcision
  • Only male patients under the age of 7 years will be eligible

Exclusion criteria

  • Any patient over 7 years of age
  • Previous circumcision
  • Any parents who are not English language speaking

Treatment and study plan

stitches and skin adhesive

Procedure

In addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound.

Other names: skin adhesive

stitches only

Procedure

standard of care

Primary outcomes

  1. Post circumcision adhesions

    Time frame: 3-6 weeks

    Evaluation for adhesions

Secondary outcomes

  1. Parent satisfaction and comfort level with circumcision results

    Time frame: 3-6 weeks

    Parent survey at follow-up visit.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Acronym: Circglue

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Feb 18, 2013
Registry last updated
Jan 10, 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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