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

Not Applicable

Not yet recruiting

• Conditions: Shoulder Arthroplasty; Positive C. Acnes Culture

• Registration Number: NCT06831422
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Study Start: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-03
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of C. Acnes	up to 18 days	C. Acnes cultures will be sampled from surgical site prior to the initial incision (skin culture), from the incision site after the initial incision (dermal culture), from the glenohumeral joint (glenohumeral joint culture), and from the room air (air culture). Each culture will be monitored for up to 18 days for growth of C. Acnes.

Secondary Outcome Measures

Name	Time	Method
Number and Types of Complications	up to 1 year postop.	Patients will be closely monitored for intraoperative and postoperative complications and any sign of adverse reactions to these solutions.
Number of Subjects that Require Postoperative Reoperations	up to 1 year postop	Whether or not patients require another operation will be documented. The number of patients requiring postoperative reoperation will be compared between groups.

Trial Locations

Locations (1)

Henry Ford Health; 🇺🇸 Detroit, Michigan, United States