Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
NCT ID: NCT04028401
Last Updated: 2025-05-01
Study Results
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Basic Information
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RECRUITING
PHASE3
110 participants
INTERVENTIONAL
2020-06-19
2029-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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5 % benzoyl peroxide topical treatment
Application of 5% benzoyl peroxide
5% benzoyl peroxide
Application of 5% benzoyl peroxide during 5 days before the procedure
No topical treatment
No intervention
No interventions assigned to this group
Interventions
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5% benzoyl peroxide
Application of 5% benzoyl peroxide during 5 days before the procedure
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
MALE
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Stéphane CORVEC
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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CHU d'Angers
Angers, , France
CHU de Brest
Brest, , France
CHU de Limoges
Limoges, , France
CHU de Nantes
Nantes, , France
CHU de Rennes
Rennes, , France
CHU de Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Stéphane CORVEC
Role: primary
Other Identifiers
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RC19_0042
Identifier Type: -
Identifier Source: org_study_id
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