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Optimization of skin preparation to reduce Cutibacterium acnes colonization in superficial and deep samples during prosthetic shoulder surgery in male patients
EU CTIS ID: 2024-515584-56-00
What this study is testing
Evaluate the efficacy of daily application, during the 5 days preceding the procedure, of a 5% benzoyl peroxide topical treatment in the surgical skin incision area, on the reduction of Cutibacterium acnes bacterial load in the dermis of the approach to shoulder arthroplasty in men.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Patient with arthroplasty for resumption of previous shoulder surgery or failure of arthroplasty
- 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
- patient with an infectious site
- Major under guardianship
See the full eligibility 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
- Patient with arthroplasty for resumption of previous shoulder surgery or failure of arthroplasty
- 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
- patient with an infectious site
- Major under guardianship
- Patient under the protection of justice
- Patient not covered by social security
- Patient with arthroplasty for acute trauma
- Patient on immunosuppressive 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.