Actively Recruiting
Application of a Novel Antimicrobial Wash Versus Hydrogen Peroxide Versus Povidone-iodine to the Skin During Shoulder Replacement Surgery to Study Cutibacterium Acnes Infection Rates
Led by Henry Ford Health System · Updated on 2025-06-04
150
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
H
Henry Ford Health System
Lead Sponsor
N
Next Science TM
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial studies adults undergoing primary shoulder replacement surgery to compare the effects of different post-incision antimicrobial washes on the presence of Cutibacterium acnes (C. Acnes) bacteria. The goal is to find out whether applying these solutions after the initial incision can reduce positive C. Acnes cultures, which are linked to infections. Participants are adults with shoulder conditions like severe osteoarthritis or rotator cuff arthropathy who have not improved after conservative treatment. Participants are randomly assigned to one of four groups: Xperience Antimicrobial Wash, 3% hydrogen peroxide, 10% povidone-iodine (betadine), or no post-incision treatment (control). Each antimicrobial is applied along the entire dermis with a soaked surgical sponge right after the initial incision. The control group does not receive any dermal treatment before bacterial cultures are collected. During the study, cultures are taken from the surgical site before and after incision, the shoulder joint, and the operating room air. These cultures are monitored daily up to 18 days after surgery for C. Acnes. Patients have follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year to assess wound healing and complications. Data from medical records and clinical evaluations are collected and analyzed to understand the treatment effects and any surgical complications.
CONDITIONS
Brief Title
Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for primary shoulder replacement surgery
- Diagnosed with chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, or rotator cuff arthropathy
- Able to read and understand English
- Age 18 years or older
- Failed at least 6 weeks of conservative treatment including anti-inflammatory drugs
You will not qualify if you...
- History of prior infection or septic arthritis in the affected shoulder
- Previous surgery on the shoulder to be treated
- Proximal humerus fracture
- Active infection
- Cancer
- Autoimmune or rheumatologic disorders such as rheumatoid arthritis, psoriatic arthritis, or lupus
- History of allergy to citric acid-derived products
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo shoulder replacement surgery with application of one of three antimicrobial washes or no treatment to the dermal layer during surgery. Cultures are collected from the surgical site, incision site, shoulder joint, and room air during the procedure.
1 surgical visit (in-person)
Duration - Up to 1 year
Participants are monitored for the presence of C. Acnes through cultures for up to 18 days after surgery. Clinical evaluations of wound healing and complications are conducted at postoperative clinic visits.
Clinic visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-surgery
Trial Site Locations
Total: 1 location
1
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
Research Team
C
Chimdindu Obinero, BS
J
Jared Mahylis, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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