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Completed

NCT Number: NCT02593903

Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair

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.

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Key information

Conditions

Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Age range

6 month–2 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Septra

Drug

Other names: Bactrim, Sulfamethoxazole/trimethoprim

Primary outcomes

  1. Number of Participants With Urinary Tract Infection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Children's Hospital and Health System Foundation, Wisconsin

Registry information

Official study title

Prophylactic Antibiotics Following Distal/Mid-shaft Hypospadias Repair: Are They Necessary?

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Nov 2, 2015
Registry last updated
Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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