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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Mar 2026 → May 2027
See other at-risk trials from Henry Ford Health System

Record History

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  1. Primary completion pushed from Mar 2026 to May 2027 Show 4 more changesShow less
    • Study completion pushed from Sep 2027 to Dec 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 4 words
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
  3. Start date: Mar 1, 2025 to May 5, 2025
    • Site contact updated
    v4
  4. Primary endpoint revised
    • Study description revised
    • Study title revised
    v3
  5. Study completion date: Mar 2027 to Sep 2027
    • Secondary endpoints revised (2)
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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 have an equal reduction in the incidence of C. acnes as Hydrogen Peroxide.
Trial Details
NCT Number NCT06831422
Lead Sponsor Henry Ford Health System
Collaborators: Next Science TM
Conditions
(from sponsor)		 Shoulder Arthroplasty, Positive C. Acnes Culture
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov