Recruiting

Xperience Antimicrobial

Sponsor:

Henry Ford Health System

Code:

NCT06831422

Conditions

Shoulder Arthroplasty

Positive C. Acnes Culture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Povidone-Iodine

Hydrogen Peroxide

Xperience Antimicrobial Wash

Bacterial Cultures

Shoulder Arthroplasty

Study Details

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

Study ID

NCT06831422

Start date

May 5, 2025

Status verified date

May, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

experimental: 3% hydrogen peroxide

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

experimental: 10% povidone-iodine

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

active comparator: Control

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

Interventions

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).

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).

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).

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)

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.

Primary outcome measure

  • Incidence of C. Acnes [ Time Frame: up to 18 days ]

Central Contacts and Locations

Central contacts

Chimdindu Obinero, BS

678-230-8592cobiner1@hfhs.org

Jared Mahylis, MD

313-916-2181jmahyli1@hfhs.org

Locations

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Chimdindu Obinero, BS

678-230-8592cobiner1@hfhs.org

Jared Mahylis, MD

313-916-2181jmahyli1@hfhs.org

Principal Investigator:

Jared Mahylis, MD

More Information

Sponsor

Henry Ford Health System

Last update posted

Jun 4, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2025-06-04.