Efficacy of Combination of Topical Benzoyl Peroxide and Electrocautery Skin Incision in Eradicating Cutibacterium Acnes From Surgical Wounds During Shoulder Arthroplasty

2095111

The goal of this prospective randomized clinical trial is to investigate the potential synergistic effect of combination of topical benzoyl peroxide and making skin incision with electrocautery on preventing surgical wound contamination from Cutibacterium acnes (C. acnes) in patients undergoing shoulder replacement. The main question it aims to answer is: • Will the combined use of topical application of benzoyl peroxide and making skin incision using electrocautery decrease the positive culture rates of C. acnes in the surgical field? Participants will be asked to apply topical benzoyl peroxide to the shoulder skin prior to their shoulder replacement surgery if they are randomized in the treatment group. The skin incision will be made using electrocautery in both the control and treatment groups. Microbiology swab cultures will be taken during shoulder replacement surgery to compare the positive culture rates for C. acnes between the groups.

2024-06-01

2025-07-30

2025-08-30

Not yet recruiting

Early phase I

70

Inclusion Criteria: * Adult male patients (\>18 years old) who will undergo primary shoulder arthroplasty (either anatomic or reverse) secondary to osteoarthritis, cuff tear arthropathy, or massive irreparable rotator cuff tear. Exclusion Criteria: * History of ipsilateral open shoulder procedures * History of ipsilateral shoulder infection (either native or postoperative infection) * Intake of any preoperative antibiotics within one month prior to index surgery * Active acne at surgical site * History of psoriatic or eczematous lesions to the surrounding shoulder region * History of allergic reactions to benzoyl peroxide * Planned for revision arthroplasty surgery * Minors under the age of 18 years old * Female patients * Prisoners * Workers compensation insurance status * Surgery planned for acute proximal humerus fracture or fracture sequelae (nonunion or malunion) * Patients who cannot understand English well enough to adequately provide informed consent.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

2023-10-31