Reducing Cutibacterium Acnes in Shoulder Surgery

Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients

This study is testing if using a benzoyl peroxide cream on the skin for five days before shoulder surgery can help reduce a bacteria that may cause infections in men having shoulder operations.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Nantes University Hospital (Academic / other)
• Locations: 6 sites (Angers and 5 other locations)
• Trial ID: NCT04028401 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of applying a 5% benzoyl peroxide topical treatment on the skin before shoulder surgery to reduce the presence of Cutibacterium acnes, a bacterium linked to post-operative infections. The study focuses on male patients undergoing various types of shoulder arthroplasty for conditions like osteoarthritis or rotator cuff tears. By applying the treatment for five days prior to surgery, the researchers hope to decrease the bacterial load in the surgical area, potentially improving surgical outcomes. The trial is interventional and is currently in Phase 3.

Who should consider this trial

Good fit: Ideal candidates for this study are adult male patients scheduled for shoulder arthroplasty without prior surgeries on the same shoulder.

Not a fit: Patients with a history of shoulder surgery, acute trauma, or certain medical conditions such as cancer or immunosuppression may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly lower the risk of post-operative infections in male patients undergoing shoulder surgery.

How similar studies have performed: While the specific application of benzoyl peroxide in this context may be novel, similar studies have shown that optimizing skin preparation can reduce infection rates in surgical settings.

Eligibility criteria

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

Where this trial is running

Angers and 5 other locations

• CHU d'Angers — Angers, France (Recruiting)
• CHU de Brest — Brest, France (Recruiting)
• CHU de Limoges — Limoges, France (Recruiting)
• CHU de Nantes — Nantes, France (Recruiting)
• CHU de Rennes — Rennes, France (Recruiting)
• CHU de Tours — Tours, France (Recruiting)

Study contacts

• Principal investigator: Stéphane CORVEC — Nantes University Hospital
• Study coordinator: Stéphane CORVEC

Conditions Cutibacterium Acnes Infection