The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision (Circ glue)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2016 by Children's Mercy Hospital Kansas City
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 27, 2016
Last verified: January 2016
- 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: application of 2-octyl cyanoacrylate skin adhesive in addition to stitches Procedure: standard stitches only |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 Children's Mercy Hospital Kansas City:
Primary Outcome Measures:
- Post circumcision adhesions [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]Evaluation for adhesions
Secondary Outcome Measures:
- Parent satisfaction and comfort level with circumcision results [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]Parent survey at follow-up visit.
| Estimated Enrollment: | 336 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | June 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Stitches only
Stitches only closing circumcision wound
|
Procedure: standard stitches only
standard of care
Other Name: stitches only
|
|
Experimental: Stitches plus 2-octyl cyanoacrylate skin adhesive
application of 2-octyl cyanoacrylate skin adhesive.
|
Procedure: application of 2-octyl cyanoacrylate skin adhesive in addition to stitches
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) |
| Genders 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
Contacts
| Contact: Shawn D St. Peter, MD | 816-983-6479 | sspeter@cmh.edu | |
| Contact: Susan W Sharp, PhD | 816-983-6670 | swsharp@cmh.edu |
Locations
| United States, Missouri | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Shawn D St. Peter, MD 816-983-6479 sspeter@cmh.edu | |
| Contact: Susan W Sharp, PhD 816-983-6670 swsharp@cmh.edu | |
| Principal Investigator: Shawn D St. Peter, MD | |
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 27, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 30, 2016