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

NCT ID: NCT01794221

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

422 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Phimosis Adhesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Stitches only

Stitches only closing circumcision wound

Group Type ACTIVE_COMPARATOR

stitches only

Intervention Type PROCEDURE

standard of care

Stitches and skin adhesive

application of 2-octyl cyanoacrylate skin adhesive.

Group Type EXPERIMENTAL

stitches and skin adhesive

Intervention Type PROCEDURE

In addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound.

Interventions

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stitches and skin adhesive

In addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound.

Intervention Type PROCEDURE

stitches only

standard of care

Intervention Type PROCEDURE

Other Intervention Names

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skin adhesive

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Shawn St. Peter

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shawn D St. Peter, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital and Clinics

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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1290443

Identifier Type: -

Identifier Source: org_study_id

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