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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
Sponsor:
Information provided by (Responsible Party):
Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social

Brief Summary:
Urethrocutaneous fistulae (UCF) represent one of the most frequent causes of morbidity after urethroplasty. Hypospadias can be repaired using different surgical techniques, but regardless of technique, the incidence of UCF ranges between 10% and 40%. The surgical repair of UCF remains the treatment of choice, even if some patients need further operations because of recurrences. The cyanoacrylates have been used as skin suture substitutes, and some evidence suggests a beneficial effect when these adhesives are used as an adjuvant in the management of UCF.

Condition or disease Intervention/treatment Phase
Urethrocutaneous Fistulas. Device: 2-octylcyanoacrylate Procedure: Surgical reintervention Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: 2-octylcyanoacrylate
Application of 2-octylcyanoacrylate
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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Morbidity after applications [ Time Frame: 12 months after the procedure. ]
    Morbidity after applications of cyanoacrylates or surgical reintervention.



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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children younger than 5 years old with at least one postoperative UCF with an external orifice less than 5 mm in diameter at the distal, proximal or medial penis,
  • Patients whose parents or guardians accepted inclusion in the study by signing the informed consent form

Exclusion Criteria:

  • Patients with an external orifice more than 5 mm in diameter
  • Iatrogenic or traumatic fistulae
  • The presence of obstruction distal to the fistula, necrotic tissue or active infection at the surgical site,
  • The presence of chronic diseases such as diabetes mellitus, renal or hepatic insufficiency, malignancy of any type or use of steroids and/or immunosuppressive therapy of any kind,

Information from the National Library of Medicine

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


Locations
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Mexico
Department of Pediatric Surgery of the Pediatrics Hospital of the Western Medical Center of the Mexican Institute of Social Security
Guadalajara, Jalisco, Mexico, 44340
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Principal Investigator: Alejandro González-Ojeda, Ph.D., M.D. Instituto Mexicano del Seguro Social

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alejandro Gonzalez-Ojeda, PhD. MD, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT02115191     History of Changes
Other Study ID Numbers: Cyanoacrylate-2014-03
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social:
2-octylcyanoacrylate
Urethrocutaneous fistulas.
Closure.
Recurrence.
Additional relevant MeSH terms:
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Fistula
Pathological Conditions, Anatomical