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

NCT06831422 | Recruiting FDA Device

• 1 other identifier: 17996
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthroplasty; Positive C. Acnes Culture

Keywords

Shoulder Arthroplasty; Antimicrobial; Post-incision wash; C. Acnes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number and Types of Complications

  up to 1 year postop.

• Number of Subjects that Require Postoperative Reoperations

  up to 1 year postop

Study Arms (4)

Xperience Antimicrobial Wash

EXPERIMENTAL

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; Diagnostic Test: Bacterial Cultures; Procedure: Shoulder Arthroplasty

3% hydrogen peroxide

EXPERIMENTAL

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

Device: Hydrogen Peroxide; Diagnostic Test: Bacterial Cultures; Procedure: Shoulder Arthroplasty

10% povidone-iodine

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Diagnostic Test: Bacterial Cultures; Procedure: Shoulder Arthroplasty

Interventions

Povidone-Iodine DEVICE

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).

Hydrogen Peroxide DEVICE

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).

3% hydrogen peroxide

Xperience Antimicrobial Wash DEVICE

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).

Xperience Antimicrobial Wash

Bacterial Cultures DIAGNOSTIC_TEST

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)

3% hydrogen peroxide; Control; Xperience Antimicrobial Wash

Shoulder Arthroplasty PROCEDURE

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.

3% hydrogen peroxide; Control; Xperience Antimicrobial Wash

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• Next Science TM: collaborator

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Shoulder

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Chimdindu Obinero, BS

CONTACT

678-230-8592; cobiner1@hfhs.org

Jared Mahylis, MD

CONTACT

313-916-2181; jmahyli1@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon, Prinicipal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: May 5, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)