Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair

Not Applicable

Completed

• Conditions: Hypospadias
• Interventions: Drug: Septra

• Registration Number: NCT02593903
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

The purpose of this study is to evaluate the efficacy of prophylactic antibiotics following distal or mid-shaft hypospadias repair in influencing the rate of postoperative urinary tract infection and complications.

Detailed Description

The rationale for using prophylactic antibiotics after hypospadias surgery is to decrease the occurrence of urinary tract infections (UTIs) and complications. However, even though prophylactic antibiotics are used by some pediatric urologists, to date there has been no evidence supporting the role of prophylactic antibiotics in decreasing UTIs or complications. This is a prospective, randomized trial involving children undergoing distal or mid-shaft hypospadias repair. Subjects randomized into a group taking prophylactic dosages of antibiotics and a group not receiving post-operative antibiotics.

Study Timeline

• Study Start: 2014-03-04
• Study First Submitted: 2015-10-30
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Primary Completion: 2017-06-30
• Study Completion: 2018-04
• Results First Submitted: 2018-09-17
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-02
• Last Update Submitted: 2018-11-02
• Results First Posted: 2018-11-05
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 67

Inclusion Criteria

• all children between ages 6 months to 2 years under going distal or mid shaft hypospadias repair
• children of parents who give informed consent
• English speaking
• participant must be available for follow-up 3 and 12 months post-surgery

Exclusion Criteria

• all proximal hypospadias and redo hypospadias repairs
• children who are allergic to sulfa medications
• patients who have UTI at time of surgery (proven by culture)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotics Group	Septra	Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Urinary Tract Infection	4-8 days post-operation	Urinary tract infection (UTI) will be diagnosed based on urine culture positive at 50,000CFUs per mL with one or both of the following: fever \>38 Celsius, or significant fussiness and irritability with voiding per parent report. Asymptomatic bacteriuria is known and expected in this population; therefore culture positive results alone will not be sufficient to meet the definition of UTI.

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States