Prophylactic Antibiotics or Placebo After Hypospadias Repair

Condition(s) targeted: Hypospadias

Intervention: trimethoprim-sulfamethoxazole (Drug); placebo (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Ann & Robert H Lurie Children's Hospital of Chicago

Official(s) and/or principal investigator(s):
Earl Y Cheng, MD, Principal Investigator, Affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
Mark A Faasse, MD, MPH, Study Director, Affiliation: Ann & Robert H Lurie Children's Hospital of Chicago

Overall contact:
Mark A Faasse, MD, MPH, Phone: (312) 227-6743, Email: mfaasse@luriechildrens.org

The primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics is beneficial or unnecessary after hypospadias repair.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

postoperative infection

wound-healing complications

Secondary outcome:

adverse drug reaction

C. difficile colitis

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.

Minimum age: N/A. Maximum age: 5 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- mid-to-distal shaft hypospadias

- single-stage hypospadias repair with circumcision

- 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

- HIV/AIDS, poorly controlled diabetes mellitus or other immunocompromising conditions

- 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

Mark A Faasse, MD, MPH, Phone: (312) 227-6743, Email: mfaasse@luriechildrens.org

Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois 60611, United States; Recruiting
Mark A Faasse, MD, MPH, Phone: 312-227-6743, Email: mfaasse@luriechildrens.org
Theresa Meyer, MS, RN, CPN, Phone: (312) 227-6734, Email: tmeyer@luriechildrens.org
Earl Y Cheng, MD, Principal Investigator
Dennis B Liu, MD, Sub-Investigator
Mark A Faasse, MD, MPH, Sub-Investigator

The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Not yet recruiting
Walid A Farhat, MD, Principal Investigator

Starting date: March 2014
Last updated: October 27, 2014