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The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision (Circglue)
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01794221
First received: February 15, 2013
Last updated: January 6, 2017
Last verified: January 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Phimosis Adhesions | Procedure: stitches and skin adhesive Procedure: stitches only |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision |
Resource links provided by NLM:
Further study details as provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:
Primary Outcome Measures:
- Post circumcision adhesions [ Time Frame: 3-6 weeks ]Evaluation for adhesions
Secondary Outcome Measures:
- Parent satisfaction and comfort level with circumcision results [ Time Frame: 3-6 weeks ]Parent survey at follow-up visit.
| Enrollment: | 422 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | up to 7 Years (Child) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01794221
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794221
Locations
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
| Principal Investigator: | Shawn D St. Peter, MD | Children's Mercy Hospital and Clinics |
More Information
| Responsible Party: | Shawn St. Peter, Associate Professor, Children's Mercy Hospital Kansas City |
| ClinicalTrials.gov Identifier: | NCT01794221 History of Changes |
| Other Study ID Numbers: |
1290443 |
| Study First Received: | February 15, 2013 |
| Last Updated: | January 6, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Shawn St. Peter, Children's Mercy Hospital Kansas City:
|
circumcision 2 octyl cyanoacrylate phimosis |
Additional relevant MeSH terms:
|
Tissue Adhesions Phimosis Cicatrix Fibrosis |
Pathologic Processes Penile Diseases Genital Diseases, Male |
ClinicalTrials.gov processed this record on September 21, 2017