Prophylactic Antibiotics or Placebo After Hypospadias Repair (PROPHY)

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Active, not recruiting

Conditions: Hypospadias

Treatments: Other: placebo; Drug: trimethoprim-sulfamethoxazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02096159

LC/Uro-MF-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: Male

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 2 patient groups, including a placebo group

Antibiotics

Experimental group

Description:

trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days

Treatment:

Drug: trimethoprim-sulfamethoxazole

Placebo

Placebo Comparator group

Description:

placebo oral suspension, 0.5 mL/kg twice daily for 10 days

Treatment:

Other: placebo