Irrisept C.Acnes Study

Study Overview
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Brief Summary
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A Prospective, Randomized, Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes

Detailed Description
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The purpose of this prospective randomized control trial is to access outcomes of positive culture growth of C. acnes from specimens obtained from the shoulders of patients undergoing primary shoulder arthroplasty whose intraoperative management includes Irrisept antiseptic irrigation and compare it to patients whose management includes standard of care prophylaxis wipes.

Official Title
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Effect of Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate (Irrisept) on Incidence of Cutibacterium Acnes in Shoulder Arthroplasty

Conditions
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Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty

Intervention / Treatment
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* Drug: Antiseptic Cleanser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has signed the IRB-approved informed consent form specific to this study prior to undergoing any research related procedures Patient can read and understand English Patient who will undergo a primary shoulder arthroplasty Patient is over the age of 18 Exclusion Criteria: Patient who has had a previous surgery on the ipsilateral shoulder Patient has a known allergy to topical iodine or Chlorohexidine gluconate. Patient has had non-surgical prophylaxis antibiotic treatment within 14 days of index surgery Patient requires a revision procedure for a previous ipsilateral shoulder surgery Patient has any significant pathology that, in the opinion of investigator, makes the patient unsuitable for study participation Patient is a pregnant woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Randomized, Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antiseptic Cleanser<br>Standard prophylaxis will be administered by Irrisept patients as would individuals in the control group. In addition, these Irrisept study subjects will be supplemented with the use of Irrisept irrigation by the study surgeon during the patient's surgical procedure. Standard times for irrigation will include immediately after incision through the dermal layer, and immediately prior to implantation of any prosthetic components. Final irrigation will be performed just prior to closure of the deltopectoral interval. | Drug: Antiseptic Cleanser<br>* Contains 0.05% Chlorhexidine gluconate in sterile water for irrigation. The mechanical action of the Irrisept system removes bacteria and debris without harming underlying tissues. Irrisept has demonstrated broad spectrum bactericidal activity against antibiotic-resistant strains. Its contents are wrapped in two sequential sterilization wraps which repel water blood, and saline, making it effective against both air and water borne bacteria.<br>* Other names: Irrisept Wound Cleansing System;|
| No Intervention: Standard of Care Prophylaxis<br>Standard prophylaxis includes use of chlorhexidine wipes (Sage cloth) the night before and morning of surgery on the surgical site over the anterior shoulder. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C.acnes Growth Rate | To compare the rate of C.acnes using two different antiseptic protocols | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: [0 (no pain) - 10 (worse possible pain)] | 6 months | 
| ROM | Range of Motion | 6 Months | 
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) | the Society of the American Shoulder and Elbow Surgeons to facilitate standardization of outcome measures. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder Arthroplasty, C.acnes, Cutibacterium acnes, Irrisept