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Clinical Trials in Canada / NCT02096159
Active, not recruiting Not applicable

Prophylactic Antibiotics or Placebo After Hypospadias Repair

NCT02096159 · tracked via the Priya Life Science Canada tracker
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Phase
Not applicable
Started
2014-03
Last updated
2024-11-14

Condition(s) studied

Hypospadias

Investigational drug(s) / intervention(s)

trimethoprim-sulfamethoxazole →placebo

Study summary

The primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.

Eligibility

Sex
MALE
Min age
—
Max age
5 Years
Healthy volunteers
No
Inclusion Criteria: * mid-to-distal shaft hypospadias * single-stage hypospadias repair * length of urethral repair (urethroplasty) less than or equal to 20 mm * placement of an open-drainage urethral stent at the time of hypospadias repair, with intended duration of stenting for 5-10 days post-operatively Exclusion Criteria: * previous hypospadias repair * prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole * cross-reactivity of an existing medication with trimethoprim-sulfamethoxazole * any patient condition with elevated risk of infection or adverse outcome from potential infection (e.g., HIV/AIDS, poorly controlled diabetes mellitus or other immunocompromising conditions, congenital heart disease) * use of antibiotics within seven days prior to hypospadias repair * foreskin reconstruction at the time of hypospadias repair * prescription of oral antibiotics other than Study Medication at the time of hypospadias repair

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois
The Hospital for Sick Children Toronto Ontario
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02096159 on ClinicalTrials.gov ↗ ← All trials in Canada