Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair

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

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-01-01

Brief Summary

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

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Detailed Description

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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

Conditions

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Hypospadias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer.

Cases of the control group (II) underwent the same procedure without using cyanoacrylate.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

patients and their relatives were blinded to the type of the intervention

Study Groups

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Cases of group (I) cyanoacrylate glue

Cases of group (I) underwent multilayered closure using dartos facial flap and cyanoacrylate glue as an interposition layer.

Group Type EXPERIMENTAL

Cyanoacrylate, Isobutyl

Intervention Type DRUG

using cyanoacrylate in the surgical repair of urethro-cutaneous fistula

Cases of the control group (II) , classic repair

Cases of the control group (II) underwent the same procedure without using cyanoacrylate.

Group Type ACTIVE_COMPARATOR

Classic surgical repair

Intervention Type PROCEDURE

classical repair of urethro-cutaneous fistula without the use of cyanoacryalte

Interventions

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Cyanoacrylate, Isobutyl

using cyanoacrylate in the surgical repair of urethro-cutaneous fistula

Intervention Type DRUG

Classic surgical repair

classical repair of urethro-cutaneous fistula without the use of cyanoacryalte

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

MALE

Accepts Healthy Volunteers

No