Clincosm LogoSign in Get a demo

PROPHY: Prophylactic Antibiotics or Placebo After Hypospadias Repair

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02096159
Collaborator
The Hospital for Sick Children (Other)
93
Enrollment
2
Locations
2
Arms
111
Anticipated Duration (Months)
46.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial
Actual Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Antibiotics

trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days

Drug: trimethoprim-sulfamethoxazole
Placebo Comparator: Placebo

placebo oral suspension, 0.5 mL/kg twice daily for 10 days

Other: placebo

Outcome Measures

Primary Outcome Measures

  1. postoperative infection [up to 30 days]

    UTI; cellulitis/wound infection

  2. wound-healing complications [up to 5 years]

    meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum

Secondary Outcome Measures

  1. adverse drug reaction [up to 14 days]

  2. C. difficile colitis [up to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 5 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois United States 60611
2 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8

Sponsors and Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • The Hospital for Sick Children

Investigators

  • Principal Investigator: Earl Y Cheng, MD, Ann & Robert H Lurie Children's Hospital of Chicago
  • Principal Investigator: Mark A Faasse, MD, MPH, Ann & Robert H Lurie Children's Hospital of Chicago

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Earl Y Cheng, MD, Head, Division of Urology, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT02096159
Other Study ID Numbers:
  • LC/Uro-MF-01
First Posted:
Mar 26, 2014
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Keywords provided by Earl Y Cheng, MD, Head, Division of Urology, Ann & Robert H Lurie Children's Hospital of Chicago
Hypospadias
Anti-Bacterial Agents
Additional relevant MeSH terms:
Hypospadias
Trimethoprim
Trimethoprim, Sulfamethoxazole Drug Combination
Sulfamethoxazole

Study Results

No Results Posted as of Mar 2, 2022