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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Arthroplasty; Positive C. Acnes Culture
• Intervention / Treatment: Device: Xperience Antimicrobial Wash; Procedure: Shoulder Arthroplasty; Device: Hydrogen Peroxide; Device: Povidone-Iodine; Diagnostic test: Bacterial Cultures

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chimdindu Obinero, BS; Phone Number: 678-230-8592; Email: cobiner1@hfhs.org
• Study Contact Backup: Name: Jared Mahylis, MD; Phone Number: 313-916-2181; Email: jmahyli1@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health
      • Contact: Chimdindu Obinero, BS; Phone Number: 678-230-8592; Email: cobiner1@hfhs.org
      • Contact: Jared Mahylis, MD; Phone Number: 313-916-2181; Email: jmahyli1@hfhs.org
      • Principal Investigator: Jared Mahylis, MD
      • Sub-Investigator: Stephanie Muh, MD
      • Sub-Investigator: Linoj Samuel, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xperience Antimicrobial Wash; 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.	Device: Xperience Antimicrobial Wash; Following electrocautery opening of the dermal layer, patients in the patients in the Xperience group (Group C) will receive application of the Xperience antimicrobial wash (NextScience, Jacksonville, FL) (32.5 g/L citric acid, 31.3 g/L sodium citrate, and 1.00 g/L sodium lauryl sulfate in sterile water) along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of Xperience, a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture).; Procedure: Shoulder Arthroplasty; All patients will undergo hemiarthroplasty, anatomic total shoulder arthroplasty, or reverse total shoulder arthroplasty in accordance with the appropriate indications and enrollment in this study.; Diagnostic test: Bacterial Cultures; Four C. Acnes cultures will be obtained for every patient. Once the skin has dried, a culture swab will be applied along the planned incision for all patients (skin culture). Approximately 120 seconds after application of Xperience, hydrogen peroxide or betadine, or after initial incision in the case of the control group, a culture of the dermis will then taken by dragging the culture swab along the length of the exposed dermis (dermis culture). Once the glenohumeral joint is exposed, the surgeon will apply new surgical gloves, and a culture swab will be placed into the joint and along the humeral head (glenohumeral joint culture). An additional culture will then be taken from the air in the operative suite (air culture)
Experimental: 3% hydrogen peroxide; To be applied along the entire dermis using a soaked surgical sponge following initial incision.	Procedure: Shoulder Arthroplasty; All patients will undergo hemiarthroplasty, anatomic total shoulder arthroplasty, or reverse total shoulder arthroplasty in accordance with the appropriate indications and enrollment in this study.; Device: Hydrogen Peroxide; Following electrocautery opening of the dermal layer, patients in the hydrogen peroxide group (Group A) will receive application of 3% sterile-filtered hydrogen peroxide along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of hydrogen peroxide a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture).; Diagnostic test: Bacterial Cultures; Four C. Acnes cultures will be obtained for every patient. Once the skin has dried, a culture swab will be applied along the planned incision for all patients (skin culture). Approximately 120 seconds after application of Xperience, hydrogen peroxide or betadine, or after initial incision in the case of the control group, a culture of the dermis will then taken by dragging the culture swab along the length of the exposed dermis (dermis culture). Once the glenohumeral joint is exposed, the surgeon will apply new surgical gloves, and a culture swab will be placed into the joint and along the humeral head (glenohumeral joint culture). An additional culture will then be taken from the air in the operative suite (air culture)
Experimental: 10% povidone-iodine; To be applied along the entire dermis using a soaked surgical sponge following initial incision.	Diagnostic test: Bacterial Cultures; Four cultures will be obtained for every patient. Once the skin has dried, a culture swab will be applied along the planned incision for all patients (skin culture). Approximately 120 seconds after application of Xperience, hydrogen peroxide or betadine, or after initial incision in the case of the control group, a culture of the dermis will then taken by dragging the culture swab along the length of the exposed dermis (dermis culture). Once the glenohumeral joint is exposed, the surgeon will apply new surgical gloves, and a culture swab will be placed into the joint and along the humeral head (glenohumeral joint culture). An additional culture will then be taken from the air in the operative suite (air culture); Procedure: Shoulder Arthroplasty; All patients will undergo hemiarthroplasty, anatomic total shoulder arthroplasty, or reverse total shoulder arthroplasty in accordance with the appropriate indications and enrollment in this study.; Device: Povidone-Iodine; Following electrocautery opening of the dermal layer, patients in the povidine-iodine group (Group B) will receive application of 10% sterile povidone-iodine along the entire dermis using a soaked surgical sponge. Approximately 120 seconds after application of betadine, a culture of the dermis will then be taken by dragging the culture swab along the length of the exposed dermis (dermis culture).
Active Comparator: Control; No treatment of the dermal layer will be performed prior to a collection of the bacterial cultures	Procedure: Shoulder Arthroplasty; All patients will undergo hemiarthroplasty, anatomic total shoulder arthroplasty, or reverse total shoulder arthroplasty in accordance with the appropriate indications and enrollment in this study.; Diagnostic test: Bacterial Cultures; Four C. Acnes cultures will be obtained for every patient. Once the skin has dried, a culture swab will be applied along the planned incision for all patients (skin culture). Approximately 120 seconds after application of Xperience, hydrogen peroxide or betadine, or after initial incision in the case of the control group, a culture of the dermis will then taken by dragging the culture swab along the length of the exposed dermis (dermis culture). Once the glenohumeral joint is exposed, the surgeon will apply new surgical gloves, and a culture swab will be placed into the joint and along the humeral head (glenohumeral joint culture). An additional culture will then be taken from the air in the operative suite (air culture)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of C. Acnes	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.	up to 18 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Next Science TM

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 30, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Shoulder Arthroplasty; Antimicrobial; Post-incision wash; C. Acnes
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Anti-Infective Agents, Local; Plasma Substitutes; Blood Substitutes; Anti-Bacterial Agents; Povidone; Povidone-Iodine; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: 17996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No