Prophylactic Antibiotics or Placebo After Hypospadias Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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Participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. Short- and intermediate-term results will be published after participants complete 6 months and 5 years of follow-up, respectively.

Official Title
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Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial

Conditions
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Hypospadias

Intervention / Treatment
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* Drug: trimethoprim-sulfamethoxazole
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotics<br>trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days | Drug: trimethoprim-sulfamethoxazole<br> <br> |
| Placebo Comparator: Placebo<br>placebo oral suspension, 0.5 mL/kg twice daily for 10 days | Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative infection | UTI; cellulitis/wound infection | up to 30 days | 
| wound-healing complications | meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse drug reaction |  | up to 14 days | 
| C. difficile colitis |  | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypospadias, Anti-Bacterial Agents