SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty
SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep for the Prevention of Bacterial Seeding in Total Shoulder Arthroplasty
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Saint Louis University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: No skin incision preparation
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. |
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Active Comparator: Povidone-iodine
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 |
Applied to skin incision.
Other Names:
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Experimental: SURGX Wound Gel
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.
|
Applied to skin incision.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep
Time Frame: Day 14
|
Each participant had culture swabs at end of surgical case from deep, superficial, and implant locations.
Cultures were held in the lab for 2 weeks to evaluate for the presence of bacteria.
The number of patients with at least one positive culture were compared among the three study arms.
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Day 14
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Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep
Time Frame: Day 14
|
Each participant had 5 total culture swabs at end of surgical case from deep (2), superficial (2), and implant (1) locations.
Cultures were held in the lab for 2 weeks to evaluate for the presence of bacteria.
The number of positive cultures after 2 weeks were compared among the control group and SURGX group.
|
Day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of Bacteria Within Shoulder Culture Using SURGX Wound Gel Prep vs. Povidone-iodine Prep
Time Frame: Day 14
|
Each participant had culture swabs at end of surgical case from deep, superficial, and implant locations.
Cultures were held in the lab for 2 weeks to evaluate for the presence of baceria.
The number of patients with at least one positive culture were compared among the SURGX and povidone-iodine groups.
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Day 14
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Randall Otto, MD, St. Louis University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32325
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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