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New treatment option for Cutibacterium Acnes Infection
Official title Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
ClinicalTrials.gov ID: NCT04028401
What this study is testing
What is 5% benzoyl peroxide?
5% benzoyl peroxide is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for cutibacterium acnes infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
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...
- 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
- 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)
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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Brest, France
- Limoges, France
- Nantes, France
- Rennes, France
- Tours, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Brest, France; Limoges, France; Nantes, France; Rennes, France; Tours, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.