The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision (Circglue)
|ClinicalTrials.gov Identifier: NCT01794221|
Recruitment Status : Active, not recruiting
First Posted : February 18, 2013
Last Update Posted : January 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Phimosis Adhesions||Procedure: stitches and skin adhesive Procedure: stitches only||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||422 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Post circumcision adhesions [ Time Frame: 3-6 weeks ]Evaluation for adhesions
- Parent satisfaction and comfort level with circumcision results [ Time Frame: 3-6 weeks ]Parent survey at follow-up visit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794221
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Shawn D St. Peter, MD||Children's Mercy Hospital and Clinics|