Status:
COMPLETED
The Effect of Pretreatment for Propionibacterium Acnes on Surgical Site Burden in Shoulder Arthroplasty
Lead Sponsor:
Albany Medical College
Collaborating Sponsors:
Hospital for Special Surgery, New York
Conditions:
Shoulder Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cutibacterium acnes - formally known as Propionibacter acnes (P. acnes) is the most common pathogen associated with prosthetic joint infection of the shoulder. Despite current skin preparation techniq...
Detailed Description
The study hypotheses will be tested using a prospective randomized-controlled trial of the effect of combination blue spectrum phototherapy and benzoyl peroxide on P. acnes at the shoulder arthroplast...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- All patients presenting to the practice that require a shoulder arthroplasty procedure
- English fluency and literacy
- Able to provide informed consent
- Older than 18 years of age
- Surgical indications including: primary arthritis, rotator cuff arthropathy, post-traumatic arthritis
- Primary total shoulder, hemiarthroplasty, primary reverse total shoulder or shoulder resurfacing
- Exclusion Criteria
- Subjects who have had a prior infection of the affected shoulder joint
- Recent steroid injection to the shoulder in the past 6 months
- Previous open or arthroscopic procedure of the shoulder joint
- Recent antibiotic use (within 90 days)
- Prisoners
Exclusion
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04112407
Start Date
January 10 2019
End Date
December 31 2022
Last Update
August 30 2023
Active Locations (2)
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1
Albany Medical Center
Albany, New York, United States, 12208
2
Hospital for Special Surgery
New York, New York, United States, 10021