2-octyl Cyanoacrylate for Closure of Urethrocutaneous Fistula.

PHASE3CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

January 31, 2015

Study Completion Date

March 31, 2015

Conditions
Urethrocutaneous Fistulas
Interventions
DEVICE

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.

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.

Trial Locations (1)

44340

Department of Pediatric Surgery of the Pediatrics Hospital of the Western Medical Center of the Mexican Institute of Social Security, Guadalajara

All Listed Sponsors
lead

Instituto Mexicano del Seguro Social

OTHER_GOV

NCT02115191 - 2-octyl Cyanoacrylate for Closure of Urethrocutaneous Fistula. | Biotech Hunter | Biotech Hunter