SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty

Study Overview
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Brief Summary
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Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after the skin incision has been made. Reducing the bacteria present in the deep tissues at the end of the surgery may prevent infections from developing in the future.

Detailed Description
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Cutibacterium acnes (C. acnes) prosthetic joint infection is a devastating and somewhat unique complication to shoulder arthroplasty. It is a very slow-growing, aerotolerant anaerobic, non-spore forming, gram-positive rod-shaped bacteria that takes up to 2-3 weeks to grow in a lab setting. There have been several studies assessing various agents in the fight to prevent C. acnes prosthetic joint infection. These agents include standard peri-operative measures typically taken when performing shoulder replacement surgery - pre-operative prophylactic antibiotics, pre-operative skin cleanse/wash, topical adjuvants (povidone-iodine, chlorhexidine, etc.), and intra-operative antibiotic powders. The overall infection rate of shoulder arthroplasty has been cited to be between 0.9-2.9%, with C. acnes being the most common bacterium in shoulder arthroplasty periprosthetic infections. Morbidity and cost associated with shoulder prosthetic joint infection is extremely high, requiring multiple surgeries and months of treatment to overcome the infection. One of the main issues with C. acnes is its preferred location within the body, residing within the sebaceous glands of the hair follicles, deep to the epidermis where many preoperative topical preparations to cleanse the skin prior to surgery have little affect. These glands are commonly found around the shoulder and upper back, and lead to acne. C. acnes, along with other common prosthetic joint infection bacteria, quickly create a biofilm which is impenetrable to most antibiotic agents, further stressing the importance of prevention. Recently there have been studies analyzing the effects of Benzoyl Peroxide (BPO) on C. acnes as it relates to shoulder arthroplasty in an attempt to reduce this bacterial burden prior to surgery. There have been promising results with multi-day preparation skin cleansing with benzoyl peroxide. However, there are no studies looking at intra-operative skin incision preparations targeting the region of skin where the C. acnes bacteria resides. In vitro studies show SURGX antimicrobial gel (Next Science, Jacksonville, FL) results in a marked reduction of C. acnes in addition to other common bacteria affecting prosthetic joints. This gel uses citric acid to chelate the metallic bonds of biofilm. The bacteria are then destroyed by a combination of a high osmolarity environment coupled with a surfactant. The first purpose of the study is to evaluate if a dermal layer preparation will reduce positive cultures of C. acnes after primary shoulder arthroplasty. There will be a control group consisting of no skin preparation. There will be two additional comparative groups. The second purpose of this study is to compare the use of standard povidone-iodine swab versus SURGX antimicrobial gel as an application into the dermal layer after the skin incision has been made with a skin knife to see if there is a reduction in bacterial burden in the superficial and deep tissues at the end of a primary shoulder arthroplasty. Superficial and deep cultures will be obtained at the conclusion of the shoulder replacement surgery. These cultures will be held in the lab for 2 weeks to identify if bacteria is present. The study team's hypothesis is that the SURGX antimicrobial gel will provide a greater reduction in bacterial burden compared to povidone-iodine within the deep tissues after primary shoulder arthroplasty.

Official Title
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SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep for the Prevention of Bacterial Seeding in Total Shoulder Arthroplasty

Conditions
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Surgery, Surgical Site Infection, Cutibacterium Acnes, Prosthetic-joint Infection

Intervention / Treatment
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* Drug: Povidone-Iodine
* Device: SURGX Wound Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is planned to undergo elective primary anatomic or reverse shoulder arthroplasty. Exclusion Criteria: Patient is undergoing revision shoulder replacement surgery. Patient has a known allergy to iodine, benzalkonium chloride, or polythylene glycol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No skin incision preparation<br>All patients will receive standard pre-operative prophylactic antibiotics. Participants will all receive the same preoperative external skin preparation with Hibiclens (chlorhexidine) and ChloraPrep (2% chlorhexidine gluconate / 70% isopropyl alcohol solution) prior to draping. Intra-operative irrigation will be standardized with Irrisept (chlorhexidine gluconate 0.05% in sterile water). The control group will receive no dermal layer skin preparation. At the time of the surgery, after the skin incision has been made with a skin knife, the dermal layer will not be prepped with an agent. | |
| Active Comparator: Povidone-iodine<br>At the time of the surgery, after the skin incision has been made, the dermal layer be prepped with povidone-iodine. Drug: povidone-iodine Dose: swabstick Administration: swab the incision Frequency: once | Drug: Povidone-Iodine<br>* Applied to skin incision.<br>* Other names: Betadine;|
| Experimental: SURGX Wound Gel<br>At the time of the surgery, after the skin incision has been made, the dermal layer be prepped with SURGX Wound Gel. SURGX wound gel is a topical antiseptic gel agent to be used on surgical incisions to prevent bacterial infection. | Device: SURGX Wound Gel<br>* Applied to skin incision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive culture as determined by the presence of Cutibacterium acnes (C. acnes) - Superficial | Culture swab obtained at end of surgical case from superficial skin location. | 2 weeks following surgery | 
| Positive culture as determined by the presence of Cutibacterium acnes (C. acnes) - Deep | Culture swab obtained at end of surgical case from deep tissue location. | 2 weeks following surgery | 
| Positive culture as determined by the presence of Cutibacterium acnes (C. acnes) - Implant | Culture swab obtained at end of surgical case from the prosthetic joint implant. | 2 weeks following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antimicrobial wound gel, SURGX, Betadine, Dermal layer, Skin preparation