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Antibiotic Use in Distal Hypospadias Repair

NCT03275519 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-09-07

No results posted yet for this study

Summary

Hypospadias is a common condition where the opening of the penis is not located at the tip, but along the underside of the penis. It is estimated to occur in 1/300 live male births, making it one of the most common birth defects. Degrees of hypospadias ranged from minor to severe depending on the location of the opening. Surgical repair is often required and involves placement of a catheter for the urine to drain with known urinary colonization found on prior retrospective studies. The current practice of using preventative antibiotics as long as the catheter is in place is conflicting with resent studies that show antibiotics may not be necessary to prevent urinary tract infections (UTIs).

The purpose of this study was to see how common symptomatic UTIs were after hypospadias repair surgery; and to see whether routine antibiotic use after surgery affected the rate of UTIs. Subjects were randomized to either receive antibiotics or no antibiotics after distal hypospadias repair. The research coordinator made follow-up phone calls with the family and the primary care provider (PCP) after stent removal, 30 days post surgery and after the 3 month post surgical visit.

Conditions

  • Hypospadias

Interventions

OTHER

Randomization to not receive prophylactic antibiotics after surgery.

No antibiotics were ordered after surgery.

OTHER

Randomization to receive prophylactic antibiotics after surgery

In general, the antibiotic given is a combination sulfamethoxazole/ trimethoprim oral suspension (2-3 mg trimethoprim/kg by mouth once a day); or if indicated, nitrofurantoin (1mg/kg by mouth once daily). All subjects did not receive intraoperative antibiotics.

Sponsors & Collaborators

  • Arkansas Children's Hospital Research Institute

    lead OTHER

Principal Investigators

  • Stephen Canon · Arkansas Children's Hospital, Pediatric Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
6 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-19
Primary Completion
2017-02-17
Completion
2017-04-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03275519 on ClinicalTrials.gov