Prophylactic Antibiotics or Placebo After Hypospadias Repair

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborator: The Hospital for Sick Children
• Treatments: Anti-Bacterial Agents; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

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