Prophylactic Antibiotics or Placebo After Hypospadias Repair

Not Applicable

Active, not recruiting

• Conditions: Hypospadias
• Interventions: Other: placebo; Drug: trimethoprim-sulfamethoxazole

• Registration Number: NCT02096159
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-26
• Primary Completion: 2018-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	placebo oral suspension, 0.5 mL/kg twice daily for 10 days
Antibiotics	trimethoprim-sulfamethoxazole	trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
adverse drug reaction	up to 14 days
C. difficile colitis	up to 6 months

Trial Locations

Locations (2)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Ann & Robert H Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States