2-octyl Cyanoacrylate for Closure of Urethrocutaneous Fistula.
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|ClinicalTrials.gov Identifier: NCT02115191|
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : March 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Urethrocutaneous Fistulas.||Device: 2-octylcyanoacrylate Procedure: Surgical reintervention||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Use of 2-octylcyanoacrylate for Closure Urethrocutaneous Fistulas After Urethroplasty for Hypospadias|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||March 2015|
Application of 2-octylcyanoacrylate
After sedation with midazolam (0.5 mg/kg orally) a Foley catheterization with a 10 Fr gauge siliconized catheter will be placed, with the balloon inflated with 1.5 ml water to prevent bladder spasm. After this we will apply the adhesive by using dissecting forceps to approximate the edges of the UCF, and then apply it several thin layers of OCA.
Active Comparator: Surgical reintervention
Surgical reintervention for urethrocutaneous fistula repair
Procedure: Surgical reintervention
The reoperation will consist on mobilizing dartos flaps and closing the defect in layers with absorbable sutures. Urinary bladder drainage will be provided with a 10 Fr silicone Foley catheter, with the balloon inflated with 1.5 ml water to prevent bladder spasm.
- Use of 2-octylcyanoacrylate for closure urethrocutaneous fistulas after urethroplasty for hypospadias. [ Time Frame: 12 months after procedure. ]Closure or recurrence of urethrocutaneous fistulas after cyanoacrylate application or surgical intervention.
- Morbidity after applications [ Time Frame: 12 months after the procedure. ]Morbidity after applications of cyanoacrylates or surgical reintervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115191
|Department of Pediatric Surgery of the Pediatrics Hospital of the Western Medical Center of the Mexican Institute of Social Security|
|Guadalajara, Jalisco, Mexico, 44340|
|Principal Investigator:||Alejandro González-Ojeda, Ph.D., M.D.||Instituto Mexicano del Seguro Social|