SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty
Condition: Surgery; Surgical Site Infection; Cutibacterium Acnes; Prosthetic-joint Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      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: 
      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.
    

Intervention name(s): Povidone-Iodine; SURGX Wound Gel
Intervention type(s): Drug; Device
Intervention description(s): Applied to skin incision.; Applied to skin incision.
Other intervention name(s): Betadine
Intervention MeSH terms: Povidone-Iodine; Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Antimicrobial wound gel; SURGX; Betadine; Dermal layer; Skin preparation