Clinical Trial: Prophylactic Antibiotics or Placebo After Hypospadias Repair

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

Official Title: Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial

Brief Summary: The primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.

Detailed Summary: Participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. Short- and intermediate-term results will be published after participants complete 6 months and 5 years of follow-up, respectively.
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Current Primary Outcome:

• postoperative infection [ Time Frame: up to 30 days ]
  UTI; cellulitis/wound infection
• wound-healing complications [ Time Frame: up to 5 years ]
  meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum

Original Primary Outcome:

• postoperative infection [ Time Frame: up to 1 month ]
• wound-healing complications [ Time Frame: up to 5 years ]
  meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum

Current Secondary Outcome:

• adverse drug reaction [ Time Frame: up to 14 days ]
• C. difficile colitis [ Time Frame: up to 6 months ]

Original Secondary Outcome: Same as current

Information By: Ann & Robert H Lurie Children's Hospital of Chicago

Dates:
Date Received: March 21, 2014
Date Started: March 2014
Date Completion: December 2023
Last Updated: August 4, 2016
Last Verified: August 2016