The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision (Circglue)
|Phimosis Adhesions||Procedure: stitches and skin adhesive Procedure: stitches only|
|Study Design:||Allocation: Randomized
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|
- 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.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|