Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair

May 3, 2021 updated by: Ahmed Maher Gamil Ahmed Higazy, Ain Shams University

Isoamyl 2-Cyanoacrylate Interposition in the Urethro-cutaneous Fistula Repair: A Randomized Controlled Trial.

cyanoacrylate has an impact that may aid in the successful repair of urethra-cutaneous fistula (UCF) that occur after hypospadias surgical repair

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypospadias is a common congenital urological birth defect. Urethro-cutaneous fistula (UCF) is the most common complication of surgical repair hypospadias and it remains the primary concern of surgeons dealing with hypospadias repair.

cyanoacrylate has been reported to enhance the healing process. this study tries to evaluate the clinical impact of cyanoacrylate on the repair of urethro-cutaneous fistula after surgical repair of hypospadias

this study evaluates the impact of using cyanoacrylate as an interposition substance in surgical repair of UCF after hypospadias in comparison to the classic surgical repair technique

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11361
        • Urology department - ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients with Urethro-cutaneous fistula regardless of their age were included in our study.

Exclusion Criteria:

  • Patients with fistula size more than 5 mm
  • multiple fistulas
  • uncorrected obstruction distal to the fistula
  • necrotic tissue
  • active infection at the fistula site
  • severely scarred skin
  • deficient dartos around the fistula
  • fistulas more proximal to the mid penile position
  • recurrent fistulas
  • previous history of hypersensitivity to cyanoacrylate-based products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cases of group (I) cyanoacrylate glue
Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer.
Drug: Cyanoacrylate, Isobutyl
using cyanoacrylate in the surgical repair of urethro-cutaneous fistula
Active Comparator: Cases of the control group (II) , classic repair
Cases of the control group (II) underwent the same procedure without using cyanoacrylate.
Procedure: Classic surgical repair
classical repair of urethro-cutaneous fistula without the use of cyanoacryalte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
successful repair of the fistula
Time Frame: 6 months after surgery
surgical outcome regarding the repair of urethro-cutaneous fistula, whether adequate healing occurred or recurrence is present
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: 6 months after surgery
report of the possible postoperative complications of both groups
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS 75/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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