N/A
N=67
Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair
Hypospadias
Bottom Line
View on ClinicalTrials.gov: NCT02593903 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Number of Participants With Urinary Tract Infection — 30; 22; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Septra (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- Male
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Urinary Tract Infection |
30; 22; 0; 0 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02593903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.