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NCT Number: NCT06831422

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

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.

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Key information

Conditions

Shoulder Arthroplasty Positive C. Acnes Culture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

Chimdindu Obinero, BS

CONTACT

[email protected]

678-230-8592

Jared Mahylis, MD

CONTACT

[email protected]

313-916-2181

Jared Mahylis, MD

PRINCIPAL_INVESTIGATOR

Linoj Samuel, PhD

SUB_INVESTIGATOR

Stephanie Muh, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

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)

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.

Primary outcomes

  1. Incidence of C. Acnes

    Time frame: 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 outcomes

  1. Number and Types of Complications

    Time frame: up to 1 year postop.

    Patients will be closely monitored for intraoperative and postoperative complications and any sign of adverse reactions to these solutions.

  2. Number of Subjects that Require Postoperative Reoperations

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chimdindu Obinero, BS

CONTACT

[email protected]

678-230-8592

Jared Mahylis, MD

CONTACT

[email protected]

313-916-2181

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Next Science TM

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 18, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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