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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
93
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
The Hospital for Sick Children
Toronto, Ontario, Canada
postoperative infection
Urinary tract infection; cellulitis/wound infection
Time frame: up to 30 days
wound-healing complications
meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum
Time frame: up to 5 years
adverse drug reaction
Time frame: up to 14 days
C. difficile colitis
Time frame: up to 6 months
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