Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair

NCT04876976 | Completed Phase 2 DMC

• 1 other identifier: MS 75/2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypospadias

Keywords

Isoamyl 2-cyanoacrylate; urethrocutaneous fistula; fistula repair; hypospadias

Outcome Measures

Primary Outcomes (1)

• successful repair of the fistula

  surgical outcome regarding the repair of urethro-cutaneous fistula, whether adequate healing occurred or recurrence is present

  6 months after surgery

Secondary Outcomes (1)

• postoperative complications

  6 months after surgery

Study Arms (2)

Cases of group (I) cyanoacrylate glue

EXPERIMENTAL

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

Drug: Cyanoacrylate, Isobutyl

Cases of the control group (II) , classic repair

ACTIVE COMPARATOR

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

Procedure: Classic surgical repair

Interventions

Cyanoacrylate, Isobutyl DRUG

using cyanoacrylate in the surgical repair of urethro-cutaneous fistula

Cases of group (I) cyanoacrylate glue

Classic surgical repair PROCEDURE

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

Cases of the control group (II) , classic repair

Eligibility Criteria

• Gender Eligibility Details: Hypospadias is a male urethral congenital anomaly
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Urology department - ain shams university

Cairo, 11361, Egypt

Location

MeSH Terms

Conditions

Hypospadias

Interventions

Bucrylate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyanoacrylates; Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitriles; Enbucrilate; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Tissue Adhesives; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients and their relatives were blinded to the type of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 7, 2021
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

EG (1)