The Role of 2-octyl Cyanoacrylate in Prevention of Recurr... | NCT01794221

Studies
The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision

NCT01794221

Sponsor

Children's Mercy Hospital Kansas City

Status

Completed

Last Update Posted

Jan 10, 2019Actual

Enrollment

422Actual

Phase

Not Applicable

Conditions

Phimosis
Adhesions

Interventions

stitches and skin adhesive
stitches only

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Feb 15, 2013

First Submission Date that Met QC Criteria

Feb 15, 2013

First Posted Date

Feb 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2019

Last Update Posted Date

Jan 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shawn St. Peter, Associate Professor, Children's Mercy Hospital Kansas CityPrincipal Investigator

Lead Sponsor

Children's Mercy Hospital Kansas CityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

422Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stitches only	Active Comparator	Stitches only closing circumcision wound	Procedure: stitches only
Stitches and skin adhesive	Experimental	application of 2-octyl cyanoacrylate skin adhesive.	Procedure: stitches and skin adhesive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stitches and skin adhesive	Procedure	In addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound.	Stitches and skin adhesive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post circumcision adhesions	Evaluation for adhesions	3-6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Parent satisfaction and comfort level with circumcision results	Parent survey at follow-up visit.	3-6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shawn D St. Peter, MD	Children's Mercy Hospital and Clinics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Mercy Hospital		Kansas City	Missouri	64108	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010688	Phimosis
D000267	Tissue Adhesions

Ancestor Terms

ID	Term
D010409	Penile Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053832	Surgical Tape

Ancestor Terms

ID	Term
D053831	Surgical Fixation Devices
D013523	Surgical Equipment
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided