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

Primary Purpose

Phimosis, Adhesions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
stitches and skin adhesive
stitches only
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Phimosis focused on measuring circumcision, 2 octyl cyanoacrylate, phimosis

Eligibility Criteria

1 Day - 7 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Stitches only

Stitches and skin adhesive

Arm Description

Stitches only closing circumcision wound

application of 2-octyl cyanoacrylate skin adhesive.

Outcomes

Primary Outcome Measures

Post circumcision adhesions
Evaluation for adhesions

Secondary Outcome Measures

Parent satisfaction and comfort level with circumcision results
Parent survey at follow-up visit.

Full Information

First Posted
February 15, 2013
Last Updated
January 8, 2019
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT01794221
Brief Title
The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision
Acronym
Circglue
Official Title
The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phimosis, Adhesions
Keywords
circumcision, 2 octyl cyanoacrylate, phimosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
422 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stitches only
Arm Type
Active Comparator
Arm Description
Stitches only closing circumcision wound
Arm Title
Stitches and skin adhesive
Arm Type
Experimental
Arm Description
application of 2-octyl cyanoacrylate skin adhesive.
Intervention Type
Procedure
Intervention Name(s)
stitches and skin adhesive
Other Intervention Name(s)
skin adhesive
Intervention Description
In addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound.
Intervention Type
Procedure
Intervention Name(s)
stitches only
Intervention Description
standard of care
Primary Outcome Measure Information:
Title
Post circumcision adhesions
Description
Evaluation for adhesions
Time Frame
3-6 weeks
Secondary Outcome Measure Information:
Title
Parent satisfaction and comfort level with circumcision results
Description
Parent survey at follow-up visit.
Time Frame
3-6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shawn D St. Peter, MD
Organizational Affiliation
Children's Mercy Hospital and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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