Prophylactic Antibiotics or Placebo After Hypospadias Repair (NCT02096159) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Prophylactic Antibiotics or Placebo After Hypospadias Repair
United States, Canada93 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range5 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
postoperative infection
Timeframe: up to 30 days
2
wound-healing complications
Timeframe: up to 5 years
Trial details
NCT IDNCT02096159
SponsorAnn & Robert H Lurie Children's Hospital of Chicago