Clinical trial

The Effect of Pretreatment for Propionibacterium Acnes on Surgical Site Burden in Shoulder Arthroplasty; a Pilot Study

Name
5316
Description
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 techniques, P. acnes is encountered at the skin surface and at the natural reservoir in the sebaceous glands during the surgical exposure; current levels of exposure are implicated in overall prosthetic infection risk. Therefore, this study endeavors to decrease P. acnes burden at the surgical incision using preoperative blue light phototherapy and benzyl peroxide washes targeting both the skin surface and sebaceous glands.
Trial arms
Trial start
2019-01-10
Estimated PCD
2022-12-01
Trial end
2022-12-31
Status
Completed
Treatment
Blue Light Phototherapy
Phototherapy in the blue light spectrum
Arms:
BPO and Phototherapy
Other names:
Phototherapy
Benzyl Peroxide
Benzyl peroxide wash to be used preoperatively during showering to the operative shoulder site.
Arms:
BPO Group, BPO and Phototherapy
Other names:
BPO
Control
Standard surgical site preparation with no P. acnes pretreatment
Arms:
Control
Size
120
Primary endpoint
Rate of total culture positivity during shoulder arthroplasty
14 days in culture
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}
Updated at
2023-08-30

1 organization

1 product

1 indication