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NCT01794221 Clinical Trial

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

Adhesions Clinical Trial

— Circglue  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01794221
Other study ID # 1290443
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2012
Est. completion date September 2017

Study information
Verified date January 2019
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 422
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Male
Age group N/A to 7 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• stitches and skin adhesive
In addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound.
• stitches only
standard of care

Locations
Country Name City State
United States Children's Mercy Hospital Kansas City Missouri

Sponsors (1)
Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post circumcision adhesions Evaluation for adhesions 3-6 weeks
Secondary Parent satisfaction and comfort level with circumcision results Parent survey at follow-up visit. 3-6 weeks
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