Hypospadias
Conditions
Keywords
Hypospadias, Anti-Bacterial Agents
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 description
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.
Interventions
DRUGtrimethoprim-sulfamethoxazole
OTHERplacebo
Sponsors
The Hospital for Sick Children
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
No minimum to 5 Years
Healthy volunteers
No
Inclusion criteria
* mid-to-distal shaft hypospadias * single-stage hypospadias repair * length of urethral repair (urethroplasty) less than or equal to 20 mm * placement of an open-drainage urethral stent at the time of hypospadias repair, with intended duration of stenting for 5-10 days post-operatively
Exclusion criteria
* previous hypospadias repair * prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole * cross-reactivity of an existing medication with trimethoprim-sulfamethoxazole * any patient condition with elevated risk of infection or adverse outcome from potential infection (e.g., HIV/AIDS, poorly controlled diabetes mellitus or other immunocompromising conditions, congenital heart disease) * use of antibiotics within seven days prior to hypospadias repair * foreskin reconstruction at the time of hypospadias repair * prescription of oral antibiotics other than Study Medication at the time of hypospadias repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative infection | up to 30 days | Urinary tract infection; cellulitis/wound infection |
| wound-healing complications | up to 5 years | meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum |
Secondary
| Measure | Time frame |
|---|---|
| adverse drug reaction | up to 14 days |
| C. difficile colitis | up to 6 months |
Countries
Canada, United States
Outcome results
None listed