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Completed

NCT Number: NCT04876976

Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair

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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Key information

Conditions

Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Urology department - ain shams university

Cairo, 11361, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyanoacrylate, Isobutyl

Drug

using cyanoacrylate in the surgical repair of urethro-cutaneous fistula

Classic surgical repair

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. postoperative complications

    Time frame: 6 months after surgery

    report of the possible postoperative complications of both groups

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 7, 2021
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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