Status:
RECRUITING
Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
Lead Sponsor:
Nantes University Hospital
Conditions:
Cutibacterium Acnes Infection
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 infect...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04028401
Start Date
June 19 2020
End Date
June 1 2029
Last Update
May 1 2025
Active Locations (6)
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1
CHU d'Angers
Angers, France, 49933
2
CHU de Brest
Brest, France, 29609
3
CHU de Limoges
Limoges, France, 87000
4
CHU de Nantes
Nantes, France, 44093