Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT02096159
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
5 Years
Study:
NCT02096159
Study Brief:
Protocol Section:
NCT02096159