Informations générales (source: ClinicalTrials.gov)
Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients (OPRICA)
Interventional
Phase 3
Nantes University Hospital (Voir sur ClinicalTrials)
juin 2020
juin 2029
02 mai 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU d'Angers - 49933 - Angers - France | Laurent HUBERT | Contact (sur clinicalTrials) | |||
| CHU de Brest - 29609 - Brest - France | Hoel LETISSIER | Contact (sur clinicalTrials) | |||
| CHU de Rennes - 35000 - Rennes - France | Hervé THOMAZEAU | Contact (sur clinicalTrials) | |||
| CHU de Tours - 37170 - Tours - France | Luc FAVARD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Limoges - 87000 - Limoges - France | Pierre Sylvain MARCHEIX, Pr | Contact (sur clinicalTrials) | |||
| CHU de Nantes - 44093 - Nantes - France | Stéphane CORVEC | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
- Male patients, Adult patients,
- Patient without a history of surgical intervention on the operated shoulder,
- 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.
- Patients affiliated to a social security system
- Patients who have given their informed and written consent
- Male patients, Adult patients,
- Patient without a history of surgical intervention on the operated shoulder,
- 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.
- Patients affiliated to a social security system
- Patients who have given their informed and written consent
- Patient with arthroplasty for resumption of previous shoulder surgery or failure of
arthroplasty
- Patient with arthroplasty for acute trauma
- Patient on immunosuppressantsimmunosuppressive drugs
- Patient with inflammatory rheumatism
- Patient with progressive cancer pathology
- Allergies or intolerances concerning the modalities of selected skin preparations
(Povidone Iodine, hypersensitivity to benzoyl peroxide)
- Dermatological pathologies in the area to be treated
- Acne treatment in the area to be treated within four weeks before inclusion
- Patient without possible help from a third party for the application of Cutacnyl® 5%
in the intervention group if necessary
- Major under guardianship
- Patient under the protection of justice
- Patient not covered by social security