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Wound Irrigation Comparative Effectiveness Study
The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups.
Conditions:
🦠 Cutibacterium Acnes Contamination
🗓️ Study Start (Actual) 20 March 2024
🗓️ Primary Completion (Estimated) 31 May 2025
✅ Study Completion (Estimated) 31 May 2027
👥 Enrollment (Estimated) 126
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Orange, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • • Ault patients requiring Total Shoulder Arthroplasty

    Exclusion Criteria:

    • * Age younger than 18 years
    • * History of shoulder infection
    • * Antibiotic therapy within 2 weeks of surgery
    • * Cortisone infiltration within 3 months prior to surgery
    • * Allergy to CHG
    • * Diagnosis of rheumatoid arthritis
    • * Immunocompromised patients
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 April 2024
  • First Submitted that Met QC Criteria 18 April 2024
  • First Posted 23 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 April 2024
  • Last Update Posted 26 April 2024
  • Last Verified April 2024
I'm interested ...!!