This proposal aims to investigate a novel light-based treatment to reduce morbidity in shoulder surgical patients. This has potential to improve outcomes and reduce health care utilization associated with infectious complications of shoulder arthroplasty. Participants will be healthy male volunteers at least 18 years of age. They will be on study for approximately 2 days.
Participants will have two study visits (consent plus treatment and swabs for culture). These visits will be conducted at the main UW Hospital, UW Health at the American Center, or UW Health at 1 S. Park. All visits will be conducted in reserved conference rooms at each location. Once a subject is determined to be eligible and has consented to the study, they will be randomized into one of three treatment groups. Study team has blank envelopes that contain one of the three treatment groups enclosed. After a subject consents to the study, the study team will randomly draw an envelope to assign a treatment arm. Arm 1. One group will receive 5% topical benzoyl peroxide gel plus 2% chlorhexidine gluconate with 70% isopropyl alcohol Arm 2. One group will receive blue light therapy plus 2% chlorhexidine gluconate with 70% isopropyl alcohol Arm 3. One group will receive both of the above treatments All participants will have their contralateral shoulder serve as the control (2% chlorhexidine gluconate with 70% isopropyl alcohol only). All treatment will be provided by the study team. Participants will also be asked to complete a research intake form. If C. acnes does grow for a tissue culture, Investigators plan to bank a colony of the bacterium for potential use in a future study. There will be no added risk to research subjects as no additional cultures will be taken and samples will be completely anonymized. The banked samples will simply be a colony of growth from the culture media for storage for possible future use. Samples will be banked for 5 years from the date of study completion after which time the samples will be destroyed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Gel treatment used to treat acne
Blue light therapy treatment for acne
University of Wisconsin - Madison
Madison, Wisconsin, United States
Number of Participants With C. Acnes Bacterium Culture After Treatment
Swab will be taken from skin and cultured for approximately 7 days to determine bacteria growth. This result is for the null condition following treatment with either blue light, blue light plus benzoyl peroxide or just benzoyl peroxide but before additional preparation with chlorhexidine.
Time frame: up to 2 days
Median Colony Forming Units (CFU) After Treatment
Quantitative culture analysis between treatment groups after treatment to the shoulder but before chlorhexidine preparation (null condition).
Time frame: up to 2 days
Percentage of Participants in Each Group With Positive C. Acnes Cultures
Comparison of positive Cutibacterium acnes cultures as a binary (yes/no) outcome between treatment arm and control arm following chlorhexidine (CHX) prep. Reported is the percentage of people in each group that had Cutibacterium acnes growth.
Time frame: up to 2 days
Median Colony Forming Units Per mL Treatment vs Control
Samples taken from treatment arm and control arm after chlorhexidine (CHX) preparation on both sides.
Time frame: up to 2 days
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