Cutibacterium acnes infection in shoulder arthroplasty with males
Conditions
Interventions
Trade Name: Cutacnyl 5%
Pharmaceutical Form: Gel
Sponsors
CHU de Nantes
Eligibility
Sex/Gender
Male
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: ? Patient with arthroplasty for resumption of previous shoulder surgery or failure of arthroplasty ? 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, cefazolin, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: ? Evaluate, in the context of shoulder arthroplasty in men, the effectiveness of applying 5% benzoyl peroxide to the skin incision area during the 5 days preceding the operation, on : o the bacterial load of Cutibacterium acnes on the skin, fat and capsular level ; o incidence of Cutibacterium acnes infections within 2 years of surgery. ? Evaluate, in the context of a shoulder arthroplasty in humans, the efficacy of alcoholic iodine povidone 5% (antiseptic from the operating area to the operating room) on the cutaneous bacterial load with Cutibacterium acnes; ? Characterize the different strains of Cutibacterium acnes found at the phylotypic and genotypic level; ? Evaluate the skin tolerance of the application of 5% benzoyl peroxide gel.;Primary end point(s): Number of patients in each group (interventional: benzoyl peroxide 5% for 5 days or control) with a positive Cutibacterium acnes sample at the dermis.;Timepoint(s) of evaluation of this end point: Day of the intervention (Day 0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Average number of positive intraoperative Cutibacterium acnes samples taken at the cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular. The skin sample at inclusion will allow the initial cutaneous Cutibacterium acnes bacterial load to be compared between both groups; ? Average number of positive Cutibacterium acnes skin samples before and after alcoholic surgical site antisepsis (5% alcoholic iodine povidone) in each of the two study groups; ? Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups; ? Determination of phylotype, molecular typing by Multi-Locus Sequence Typing and Single-Locus Sequence Typing techniques and comparison of Cutibacterium acnes strains by molecular biology and characterization of antibiotic resistance; ? Evaluation of the skin tolerance of the topical application from the local tolerance scale (irritation, erythema and desquamation), at the time of inclusion and at D0.;Timepoint(s) of evaluation of this end point: ? Day 0 ? Day 0 ? 2 years ? Day 0 ? Day 0 | — |
Countries
France
Contacts
Public ContactDirection recherche, CHU de Nantes
CHU de Nantes
Outcome results
None listed