ANHYDROUS BENZOYL PEROXIDE for Cutibacterium acnes infection | Shoulder prosthetic joint infection

Inclusion criteria

• {"criterion_text":"- Male patients"}
• {"criterion_text":"- Adult patients"}
• {"criterion_text":"- Patient without a history of surgical intervention on the operated shoulder"}
• {"criterion_text":"- Patient managed for glenohumeral, partial (cup or anatomical hemi-arthroplasty) or total (anatomical or inverted) glenohumeral arthroplasty placement for primary osteoarthritis, or secondary to necrosis, massive rotator cuff tear or old fracture"}
• {"criterion_text":"- Patients affiliated to a social security system"}
• {"criterion_text":"- Patients who have given their informed and written consent"}

Exclusion criteria

• {"criterion_text":"- Patient with arthroplasty for resumption of previous shoulder surgery or failure of arthroplasty"}
• {"criterion_text":"- Major under guardianship"}
• {"criterion_text":"- Patient under the protection of justice"}
• {"criterion_text":"- Patient not covered by social security"}
• {"criterion_text":"- Patient with arthroplasty for acute trauma"}
• {"criterion_text":"- Patient on immunosuppressive drugs"}
• {"criterion_text":"- Patient with inflammatory rheumatism"}
• {"criterion_text":"- Patient with progressive cancer pathology"}
• {"criterion_text":"- Allergies or intolerances concerning the modalities of selected skin preparations (Povidone Iodine, hypersensitivity to benzoyl peroxide)"}
• {"criterion_text":"- Dermatological pathologies in the area to be treated"}
• {"criterion_text":"- Acne treatment in the area to be treated within four weeks before inclusion"}
• {"criterion_text":"- Patient without possible help from a third party for the application of Cutacnyl® 5% in the intervention group if necessary"}
• {"criterion_text":"- patient with an infectious site"}

Primary endpoints

• {"endpoint_text":"- Number of patients in each group (interventional: benzoyl peroxide 5% for 5 days or control) with a positive Cutibacterium acnes sample at the dermis.","definition_or_measurement_approach":"Presence of a positive Cutibacterium acnes sample in the dermis per patient (count of patients with positive dermal CA sample in each arm)."}

Secondary endpoints

• {"endpoint_text":"- Average number of positive intraoperative Cutibacterium acnes samples taken at the cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular. The skin sample at inclusion will allow the initial cutaneous Cutibacterium acnes bacterial load to be compared between both groups","definition_or_measurement_approach":"Mean number of positive intraoperative CA samples per anatomical site (cutaneous, fat, capsular) before and after antisepsis; baseline skin sample used to compare initial bacterial load between groups."}
• {"endpoint_text":"- Average number of positive Cutibacterium acnes skin samples before and after alcoholic surgical site antisepsis (5% alcoholic iodine povidone) in each of the two study groups","definition_or_measurement_approach":"Mean number of positive skin CA samples pre- and post-alcoholic povidone-iodine antisepsis in each arm."}
• {"endpoint_text":"- Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups","definition_or_measurement_approach":"Incidence rate of prosthetic shoulder infections due to CA within 2 years post-implantation in each group."}
• {"endpoint_text":"- Determination of phylotype, molecular typing by Multi-Locus Sequence Typing and Single-Locus Sequence Typing techniques and comparison of Cutibacterium acnes strains by molecular biology and characterization of antibiotic resistance","definition_or_measurement_approach":"Molecular typing (phylotype, MLST, SLST) and comparative analysis of CA strains, including antibiotic resistance profiling."}
• {"endpoint_text":"- Evaluation of the skin tolerance of the topical application from the local tolerance scale (irritation, erythema and desquamation), at the time of inclusion and at D0","definition_or_measurement_approach":"Assessment using a local tolerance scale measuring irritation, erythema and desquamation at inclusion and on day 0."}

France

Earliest CTIS Part Ii Submission Date

12-09-2024

Latest Decision Or Authorization Date

22-04-2025

Processing Time Days

222

Number Of Sites

7

Number Of Participants

110

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France