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Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty

RecruitingNAAges 18 Years - anyAllHenry Ford Health System
NCT06831422 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of positive C. Acnes cultures collected from adults undergoing primary shoulder replacement surgery. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will receive one of the following treatments: * Post-incision application of Xperience Antimicrobial wash (NextScience, Jacksonville, FL) * Post-incision application of 3% hydrogen peroxide * Post-incision application of 10% povidone-iodine (betadine) * No post-incision treatment (control) The investigators hypothesize that the subjects treated with the antimicrobial solutions after initial incision will have lower rates of positive C. Acnes cultures. The investigators also hypothesize that post-incision application of Xperience Antimicrobial wash and Betadine will h

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📋 Eligibility rules (as published)
Inclusion Criteria: * Indicated and scheduled for primary shoulder arthroplasty. * Chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, rotator cuff arthropathy, * Ability to read and understand English * Age ≥18 years * Patient failed ≥6 weeks of conservative treatment, which included non-steroidal anti-inflammatory drugs (NSAIDS) Exclusion Criteria: * Patient with history of prior native shoulder septic arthritis or infection * Prior surgery of affected shoulder * Proximal Humerus Fracture * Active infection * Cancer * Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus * History of allergic reaction to citric acid-derived products
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What it tests

  • Povidone-Iodine
  • Hydrogen Peroxide
  • Xperience Antimicrobial Wash
  • Bacterial Cultures
  • Shoulder Arthroplasty
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Where

1 site
Henry Ford Health
Detroit, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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