Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hypospadias

Treatments: Procedure: Classic surgical repair; Drug: Cyanoacrylate, Isobutyl

Study type: Interventional

Funder types: Other

Identifiers

NCT04876976

MS 75/2018

Details and patient eligibility

About

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

Full 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

Enrollment: 40 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Cases of group (I) cyanoacrylate glue

Experimental group

Description:

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

Treatment:

Drug: Cyanoacrylate, Isobutyl

Cases of the control group (II) , classic repair

Active Comparator group

Description:

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

Treatment:

Procedure: Classic surgical repair