IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Trial record 3 of 6 for:
"Phimosis"
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 14, 2017