Clinical trial NCT02096159: Prophylactic Antibiotics or Placebo After Hypospadias Repair
Official title: Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypospadias
Keywords: Hypospadias
Anti-Bacterial Agents
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2014-03-26
Enrollment: 93
Sex: MALE
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: postoperative infection
timeFrame: up to 30 days
measure: wound-healing complications
timeFrame: up to 5 years
Secondary outcomes:
measure: adverse drug reaction
timeFrame: up to 14 days
measure: C. difficile colitis
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Earl Y Cheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Mark A Faasse, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faasse MA, Farhat WA, Rosoklija I, Shannon R, Odeh RI, Yoshiba GM, Zu'bi F, Balmert LC, Liu DB, Alyami FA, Beaumont JL, Erickson DL, Gong EM, Johnson EK, Judd S, Kaplan WE, Kaushal G, Koyle MA, Lindgren BW, Maizels M, Marcus CR, McCarter KL, Meyer T, Qureshi T, Saunders M, Thompson T, Yerkes EB, Cheng EY. Randomized trial of prophylactic antibiotics vs. placebo after midshaft-to-distal hypospadias repair: the PROPHY Study. J Pediatr Urol. 2022 Apr;18(2):171-177. doi: 10.1016/j.jpurol.2022.01.008. Epub 2022 Jan 25.