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

ConditionsShoulder ArthroplastyPositive C. Acnes Culture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient with history of prior native shoulder septic arthritis or infection

Prior surgery of affected shoulder

Proximal Humerus Fracture

Active infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

150 Participants
are divided into 4 treatment groups
Group A: Xperience Antimicrobial WashExperimental treatment 3 interventions
Group B: 3% hydrogen peroxideExperimental treatment 3 interventions
Group C: 10% povidone-iodineExperimental treatment 3 interventions
Group D: ControlActive comparator 2 interventions

Trial outcomes

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.

Time frame
up to 18 days

Secondary outcomes

1

Number and Types of Complications

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

Time frame
up to 1 year postop.
2

Number of Subjects that Require Postoperative Reoperations

Whether or not patients require another operation will be documented. The number of patients requiring postoperative reoperation will be compared between groups.

Time frame
up to 1 year postop

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry Ford Health System

Lead sponsor

Next Science TM

Collaborator

Source ClinicalTrials.gov
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