Clinical trial NCT06831422: Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty
Official title: Application of a Novel Antimicrobial Wash Versus Hydrogen Peroxide Versus Povidone-iodine to the Dermis and Incidence of Cutibacterium Acnes During Shoulder Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Arthroplasty
Positive C. Acnes Culture
Keywords: Shoulder Arthroplasty
Antimicrobial
Post-incision wash
C. Acnes
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Next Science TM
First posted: 2025-02-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All groups will receive standard presurgical preparation with standard surgical skin preparation. This begins with each subject receiving two chlorhexidine scrub brushes with which they will be instructed to scrub themselves the night before and morning of their surgery. Once in the operating room, all subjects will have their surgical site treated with Chlorhexidine Gluconate 4% soap, once with 3% hydrogen peroxide, and then twice with standard operative skin preparation agent, Chloraprep (2% chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol). No preoperative acetic acid, betadine, or benzoyl peroxide will be applied to the surgical shoulder. The intervention will only take place after the initial incision has been made. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will either receive one of the wash solutions (Xperience, Povidone, or Hydrogen peroxide) or a control group that will receive no post-incision wash.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Cultures will be collected from the following sites:

* The surgical site prior to the initial incision
* The incision site after the initial incision
* The shoulder joint
* The room air

Cultures will be monitored daily for the presence of C. Acnes up to 18 days post-surgery. At postoperative clinic visits, patients in all groups will undergo a clinical evaluation by their surgeon, which includes assessment of wound healing and any complications at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following surgery. A password-secured database and data points will be pulled from electronic medical records. Data will be analyzed and will be utilized to come to the conclusion of the study.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of C. Acnes
timeFrame: up to 18 days
Secondary outcomes:
measure: Number and Types of Complications
timeFrame: up to 1 year postop.
measure: Number of Subjects that Require Postoperative Reoperations
timeFrame: up to 1 year postop
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
Study officials:
References: