Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05919888 |
Other study ID # |
32325 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
June 26, 2023 |
Est. completion date |
November 14, 2023 |
Study information
Verified date |
November 2023 |
Source |
St. Louis University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.