NCT01794221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
422

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

4.8 years

First QC Date

February 15, 2013

Last Update Submit

January 8, 2019

Conditions

PhimosisAdhesions

Keywords

circumcision2 octyl cyanoacrylatephimosis

Outcome Measures

Primary Outcomes (1)

  • Post circumcision adhesions

    Evaluation for adhesions

    3-6 weeks

Secondary Outcomes (1)

  • Parent satisfaction and comfort level with circumcision results

    3-6 weeks

Study Arms (2)

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

stitches and skin adhesivePROCEDURE

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

Also known as: skin adhesive
Stitches and skin adhesive
stitches onlyPROCEDURE

standard of care

Stitches only

Eligibility Criteria

Age1 Day - 7 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All patients undergoing circumcision
  • Only male patients under the age of 7 years will be eligible

You may not qualify if:

  • Any patient over 7 years of age
  • Previous circumcision
  • Any parents who are not English language speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

PhimosisTissue Adhesions

Interventions

Surgical Tape

Condition Hierarchy (Ancestors)

Penile DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Shawn D St. Peter, MD

    Children's Mercy Hospital and Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 18, 2013

Study Start

November 1, 2012

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 10, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)