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

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ClinicalTrials.gov Identifier: NCT01794221
Recruitment Status : Active, not recruiting
First Posted : February 18, 2013
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Phimosis Adhesions Procedure: stitches and skin adhesive Procedure: stitches only Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
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
Study Start Date : November 2012
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


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


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: February 18, 2013    Key Record Dates
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