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

Nantes University Hospital (NUH)

Status and phase

Enrolling

Phase 3

Conditions

Cutibacterium Acnes Infection

Treatments

Drug: 5% benzoyl peroxide

Study type

Interventional

Funder types

Other

Identifiers

NCT04028401

RC19_0042

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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