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)
postoperative infection — up to 30 days Urinary tract infection; cellulitis/wound infection
wound-healing complications — up to 5 years meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum
Trial sites (2)
Facility
City
Region
Status
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.
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