Antimicrobial Wash for Shoulder Replacement Surgery
Trial Summary
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves shoulder surgery, it's best to discuss your medications with the trial team or your doctor.
What data supports the effectiveness of the treatment 10% Povidone-Iodine, 3% Hydrogen Peroxide, Xperience Antimicrobial Wash for shoulder replacement surgery?
Is the antimicrobial wash safe for use in surgeries?
Povidone-iodine, a key ingredient in the antimicrobial wash, has been used in surgeries to reduce infections, but its safety has been questioned due to occasional negative effects on wound healing and bone union. However, studies have shown it can effectively reduce post-operative infections when used in diluted form, suggesting it is generally safe when used properly.12467
How does the antimicrobial wash treatment for shoulder replacement surgery differ from other treatments?
The antimicrobial wash for shoulder replacement surgery is unique because it involves using antiseptic solutions like chlorhexidine, which are intended to reduce bacterial load on the skin before surgery. However, studies suggest that while chlorhexidine is commonly used, it may not be effective against certain bacteria like Cutibacterium, which are often found on the skin of shoulder surgery patients.238910
What is the purpose of 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
This trial is for adults undergoing primary shoulder replacement surgery. The study aims to see if washing the surgical site with different antimicrobial solutions after making an incision can reduce bacteria levels.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Post-incision application of antimicrobial solutions or no treatment during shoulder arthroplasty
Follow-up
Participants are monitored for safety and effectiveness after treatment, including wound healing and complications
Treatment Details
Interventions
- 10% Povidone-Iodine
- 3% Hydrogen Peroxide
- Xperience Antimicrobial Wash
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor
Next Science TM
Industry Sponsor