Shoulder Infection Clinical Trial
Official title:
Adjusting Skin Prep to Decrease Risk of P. Acnes Related Shoulder Infection
Propionibacterium acnes is the most common pathogen identified from a surgical site infection in the shoulder. Standard skin preps do not prevent this type of infection. Patients will undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to surgery. Bacterial burden will be determined at the time of surgery.
After surgical posting, patients will be randomized to chlorhexidine or benzoyl peroxide
group. The solutions used will be 5% benzoyl peroxide emollient foam and 4% chlorhexidine
gluconate skin cleanser. Participants will be instructed to conduct skin wash using the
appropriate solution in the shower over the operative shoulder and axilla for three mornings
prior to surgery (pre op day -2, pre op day -1, and morning of surgery). Specific
instructions will include leaving the solution on the skin for three minutes and avoiding
contact with eyes, ears, and mouth. Proper technique will be demonstrated at time of patient
recruitment and given as a handout with the wash solution provided. A reminder phone call
will occur two days before surgery to remind patients of proper procedure to improve
compliance. On the day of surgery, patients be interviewed about pre-operative compliance.
On the day of surgery, two cultures will be taken in three separate sites on both shoulders
(anterior, lateral, and posterior) using a detergent scrub technique, the current
dermatologic standard for biopsy of the deep sebaceous glands. (3,11) This procedure is
typically performed on the skin of awake patients and causes minimal pain and skin
irritation. Cultures will be evaluated in our lab. We will also test for hemolysis as a
possible indicator of a more virulent strain in the literature.
The research team may take photos of the shoulder skin being swabbed. Photos will not include
the facial or defining characteristics. Photos may be taken either in the clinic at time of
recruitment or in the operating room when samples are being taken.
Inclusion criteria: all patients undergoing open shoulder surgery or shoulder arthroscopy.
Exclusion criteria: anyone with a history of allergic reaction to chlorhexidine or benzoyl
peroxide. Anyone with a history of previous shoulder infection, current open skin lesions
around the shoulder or the use of current anti-acne medications around the shoulder.
Healthy volunteer portion: Healthy volunteers will respond to the study from fliers on
campus. A cotton swab test on both shoulders will be performed prior to any treatment. If a
threshold of P. Acnes is met (>1000 Colony Forming Units (CFUs)) then volunteers will be
randomized to the same two groups and retested after three days of unilateral treatment.
Finally, volunteers will undergo repeat cotton swab testing one week after 3 day wash was
finalized.
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