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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT06831422
Status
Recruiting
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Conditions

  • Positive C. Acnes Culture
  • Shoulder Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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.

Study Details

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.

Key Dates

Start date
May 5, 2025
Status verified
May 2025
Primary completion
Mar 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HealthDetroitMichigan48202
Chimdindu Obinero, BS
[email protected]
678-230-8592
Jared Mahylis, MD
[email protected]
313-916-2181
Jared Mahylis, MD (PRINCIPAL_INVESTIGATOR)
Stephanie Muh, MD (SUB_INVESTIGATOR)
Linoj Samuel, PhD (SUB_INVESTIGATOR)

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