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Prophylactic Antibiotics or Placebo After Hypospadias Repair

Study acronym: PROPHY
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Study completion date: Jun 2023 to Aug 2025v11
  2. Minor Enrollment target: estimated 630 to confirmed 93v10
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jun 2019 to Dec 2018
    • Study completion date: Dec 2023 to Jun 2023
    • Site details revised at 2 of 2 sites
    v9
  4. Minor Site contacts updated at 1 of 2 sitesv8
  5. Minor Eligibility criteria shortened, about 2 wordsv7
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  1. Notable Primary completion date: Dec 2017 to Jun 2019
    • Study completion date: Jul 2022 to Dec 2023
    • Eligibility criteria expanded, about 18 words
    • Site details revised at 2 of 2 sites
    v6
  2. Minor Site contacts updated at 1 of 2 sitesv5
  3. Minor Site contacts updated at 1 of 2 sites
    • Eligibility criteria shortened, about 3 words
    v4
  4. Minor Eligibility criteria expanded, about 9 words
    • Site contacts updated at 1 of 2 sites
    v3
  5. Minor Primary completion date: Jul 2017 to Dec 2017
    • Eligibility criteria shortened, about 5 words
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02096159
Lead Sponsor Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators: The Hospital for Sick Children
Conditions
(from sponsor)
Hypospadias
Related terms Hypospadias
Enrollment 93 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov