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

This study is currently recruiting participants.
Verified February 2013 by Children's Mercy Hospital Kansas City
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01794221
First received: February 15, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  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: application of 2-octyl cyanoacrylate skin adhesive in addition to stitches
Procedure: standard stitches only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Post circumcision adhesions [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]
    Evaluation for adhesions


Secondary Outcome Measures:
  • Parent satisfaction and comfort level with circumcision results [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]
    Parent survey at follow-up visit.


Estimated Enrollment: 336
Study Start Date: November 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stitches only
Stitches only closing circumcision wound
 Procedure: standard stitches only
standard of care
Other Name: stitches only
Experimental: Stitches plus 2-octyl cyanoacrylate skin adhesive
application of 2-octyl cyanoacrylate skin adhesive.
 Procedure: application of 2-octyl cyanoacrylate skin adhesive in addition to stitches
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

Ages Eligible for Study:   up to 7 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794221

Contacts
Contact: Shawn D St. Peter, MD 816-983-6479 sspeter@cmh.edu
Contact: Susan W Sharp, PhD 816-983-6670 swsharp@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Shawn D St. Peter, MD     816-983-6479     sspeter@cmh.edu    
Contact: Susan W Sharp, PhD     816-983-6670     swsharp@cmh.edu    
Principal Investigator: Shawn D St. Peter, MD            
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

No publications provided

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
Study First Received: February 15, 2013
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 22, 2013