Clinical Trial: Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Medical College of Wisconsin

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Medical College of Wisconsin

Dates:
Date Received: October 30, 2015
Date Started: February 2014
Date Completion: February 2020
Last Updated: November 21, 2016
Last Verified: November 2016