Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and De… (NCT04028401) | Clinical Trial Compass
RecruitingPhase 3
Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
France110 participantsStarted 2020-06-19
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients in each group with a positive Cutibacterium acnes sample at the dermis.