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

Henry Ford Health

Status: Not yet enrolling

Conditions: Positive C. Acnes Culture; Shoulder Arthroplasty

Treatments: Device: Xperience Antimicrobial Wash; Device: Povidone-Iodine; Diagnostic Test: Bacterial Cultures; Procedure: Shoulder Arthroplasty; Device: Hydrogen Peroxide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06831422

17996

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 4 patient groups

Xperience Antimicrobial Wash

Experimental group

Description:

Xperience Antimicrobial Wash is composed of 32.5 g/L citric acid, 31.3 g/L sodium citrate, and 1.00 g/L sodium lauryl sulfate in sterile water. It is to be applied along the entire dermis using a soaked surgical sponge following initial incision.

Treatment:

Procedure: Shoulder Arthroplasty

Diagnostic Test: Bacterial Cultures

Device: Xperience Antimicrobial Wash

3% hydrogen peroxide

Experimental group

Description:

To be applied along the entire dermis using a soaked surgical sponge following initial incision.

Treatment:

Procedure: Shoulder Arthroplasty

Device: Hydrogen Peroxide

Diagnostic Test: Bacterial Cultures

10% povidone-iodine

Experimental group

Description:

To be applied along the entire dermis using a soaked surgical sponge following initial incision.

Control

Active Comparator group

Description:

No treatment of the dermal layer will be performed prior to a collection of the bacterial cultures

Treatment:

Procedure: Shoulder Arthroplasty

Diagnostic Test: Bacterial Cultures