Prophylactic Antibiotics or Placebo After Hypospadias Repair

Hypospadias Clinical Trial

— PROPHY  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02096159
• Other study ID #: LC/Uro-MF-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2014
• Est. completion date: June 2023

Study information

• Verified date: February 2022
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 93
• Est. completion date: June 2023
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypospadias

Intervention

Drug:
• trimethoprim-sulfamethoxazole

Other:
• placebo

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	The Hospital for Sick Children

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative infection	UTI; cellulitis/wound infection	up to 30 days
Primary	wound-healing complications	meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum	up to 5 years
Secondary	adverse drug reaction		up to 14 days
Secondary	C. difficile colitis		up to 6 months