The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision (Circglue)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|