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Isoamyl 2-Cyanoacrylate in the Urethro-cutaneous Fistula Repair

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04876976
Enrollment
40
Registered
2021-05-07
Start date
2017-01-01
Completion date
2020-01-01
Last updated
2021-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypospadias

Keywords

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

Brief summary

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

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

Interventions

using cyanoacrylate in the surgical repair of urethro-cutaneous fistula

PROCEDUREClassic surgical repair

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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

Intervention model description

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.

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
successful repair of the fistula6 months after surgerysurgical outcome regarding the repair of urethro-cutaneous fistula, whether adequate healing occurred or recurrence is present

Secondary

MeasureTime frameDescription
postoperative complications6 months after surgeryreport of the possible postoperative complications of both groups

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026