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

This study is currently recruiting participants. (see Contacts and Locations)
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014