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

NARecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

May 5, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

September 30, 2027

Conditions
Shoulder ArthroplastyPositive C. Acnes Culture
Interventions
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).

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).

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).

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)

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.

Trial Locations (1)

48202

RECRUITING

Henry Ford Health, Detroit

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Next Science TM

INDUSTRY

lead

Henry Ford Health System

OTHER

NCT06831422 - Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty | Biotech Hunter | Biotech Hunter