Actively Recruiting
Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
Led by Nantes University Hospital · Updated on 2025-05-01
110
Participants Needed
6
Research Sites
467 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male adult patients
- No history of surgery on the operated shoulder
- Undergoing glenohumeral arthroplasty (partial or total) for primary osteoarthritis, necrosis, massive rotator cuff tear, or old fracture
- Affiliated with a social security system
- Provided informed and written consent
You will not qualify if you...
- Arthroplasty due to previous shoulder surgery or arthroplasty failure
- Arthroplasty for acute trauma
- Taking immunosuppressive drugs
- Having inflammatory rheumatism
- Having progressive cancer
- Allergies or intolerance to povidone iodine or benzoyl peroxide
- Skin diseases in the treated area
- Acne treatment in the treated area within 4 weeks before inclusion
- Unable to have help applying 5% benzoyl peroxide if needed
- Under major guardianship or legal protection
- Not covered by social security
AI-Screening
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Trial Site Locations
Total: 6 locations
1
CHU d'Angers
Angers, France, 49933
Actively Recruiting
2
CHU de Brest
Brest, France, 29609
Actively Recruiting
3
CHU de Limoges
Limoges, France, 87000
Actively Recruiting
4
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
5
CHU de Rennes
Rennes, France, 35000
Actively Recruiting
6
CHU de Tours
Tours, France, 37170
Actively Recruiting
Research Team
S
Stéphane CORVEC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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