Clinical Trial

Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients

Study acronym: OPRICA
Recruiting Phase 3
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Summary
Infections on joint replacements remain one of the most serious complications of orthopaedic surgery. Despite improvements in skin preparation and antibiotic prophylaxis procedures, the risk of infection of joint prosthesis is still high, particularly for shoulder prostheses, especially in men. One of the bacteria most often involved in post-operative infections for shoulder prosthesis is Cutibacterium acnes (CA). This bacterium is one of the predominant bacteria in pilosebaceous units. Eradication of this micro-organism remains difficult despite the techniques used in the preoperative phase. The objective of this protocol is to evaluate the efficacy of applying a 5% benzoyl peroxide topical during the 5 days preceding the procedure in the surgical skin incision area, which is based on local acne treatment, on the reduction of the CA bacterial load in the dermis of the approach to shoulder arthroplasty in men.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2019-07-18; most recent amendment 2025-04-28.
Status change: Not Yet Recruiting → Recruiting 2020-07-15
Trial Details
NCT Number NCT04028401
Lead Sponsor Nantes University Hospital
Conditions Cutibacterium Acnes Infection
Enrollment 110 participants
Start Date 2020-06-19
Primary Completion 2029-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2025-05-01