Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Patient with history of prior native shoulder septic arthritis or infection
Prior surgery of affected shoulder
Proximal Humerus Fracture
Active infection
Trial design
Treatments tested in this trial
- Povidone-Iodine
- Hydrogen Peroxide
- Xperience Antimicrobial Wash
- Bacterial Cultures
- Shoulder Arthroplasty
Treatment groups
150 Participants
are divided into 4 treatment groupsSponsors and collaborators
Henry Ford Health System
Lead sponsor
Next Science TM
Collaborator
Source ClinicalTrials.gov