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Prophylactic Antibiotics or Placebo After Hypospadias Repair (PROPHY)

Primary Purpose

Hypospadias

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
trimethoprim-sulfamethoxazole
placebo
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypospadias focused on measuring Hypospadias, Anti-Bacterial Agents

Eligibility Criteria

undefined - 5 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Antibiotics

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

postoperative infection
UTI; cellulitis/wound infection
wound-healing complications
meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum

Secondary Outcome Measures

adverse drug reaction
C. difficile colitis

Full Information

First Posted
March 21, 2014
Last Updated
February 11, 2022
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT02096159
Brief Title
Prophylactic Antibiotics or Placebo After Hypospadias Repair
Acronym
PROPHY
Official Title
Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias
Keywords
Hypospadias, Anti-Bacterial Agents

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotics
Arm Type
Experimental
Arm Description
trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo oral suspension, 0.5 mL/kg twice daily for 10 days
Intervention Type
Drug
Intervention Name(s)
trimethoprim-sulfamethoxazole
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
postoperative infection
Description
UTI; cellulitis/wound infection
Time Frame
up to 30 days
Title
wound-healing complications
Description
meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
adverse drug reaction
Time Frame
up to 14 days
Title
C. difficile colitis
Time Frame
up to 6 months

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Earl Y Cheng, MD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark A Faasse, MD, MPH
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35144885
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.
Results Reference
derived

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Prophylactic Antibiotics or Placebo After Hypospadias Repair

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