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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01794221
First Posted: February 18, 2013
Last Update Posted: January 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
  Purpose
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.

Condition Intervention
Phimosis Adhesions Procedure: stitches and skin adhesive Procedure: stitches only

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision

Resource links provided by NLM:


Further study details as provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Post circumcision adhesions [ Time Frame: 3-6 weeks ]
    Evaluation for adhesions


Secondary Outcome Measures:
  • Parent satisfaction and comfort level with circumcision results [ Time Frame: 3-6 weeks ]
    Parent survey at follow-up visit.


Enrollment: 422
Study Start Date: November 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stitches only
Stitches only closing circumcision wound
Procedure: stitches only
standard of care
Experimental: Stitches and skin adhesive
application of 2-octyl cyanoacrylate skin adhesive.
Procedure: stitches and skin adhesive
In addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound.
Other Name: skin adhesive

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794221


Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital and Clinics
  More Information

Responsible Party: Shawn St. Peter, Associate Professor, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT01794221     History of Changes
Other Study ID Numbers: 1290443
First Submitted: February 15, 2013
First Posted: February 18, 2013
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:
circumcision
2 octyl cyanoacrylate
phimosis

Additional relevant MeSH terms:
Tissue Adhesions
Phimosis
Cicatrix
Fibrosis
Pathologic Processes
Penile Diseases
Genital Diseases, Male