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NCT05676411
Benzoyl Peroxide and Electrocautery Skin Inicision to Eradicate Cutibacterium Acnes
Conditions: Prosthetic-joint Infection
Sex: Male
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 70
Sponsor: University of Missouri-Columbia
Location: United States
Summary
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.
Eligibility Criteria
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 proceduresHistory of ipsilateral shoulder infection (either native or postoperative infection)Intake of any preoperative antibiotics within one month prior to index surgeryActive acne at surgical siteHistory of psoriatic or eczematous lesions to the surrounding shoulder regionHistory of allergic reactions to benzoyl peroxidePlanned for revision arthroplasty surgeryMinors under the age of 18 years oldFemale patientsPrisonersWorkers compensation insurance statusSurgery planned for acute proximal humerus fracture or fracture sequelae (nonunion or malunion)Patients who cannot understand English well enough to adequately provide informed consent.
Source: ClinicalTrials.gov (NCT05676411). StuddyBuddy aggregates publicly available trial information.