Clinical trial NCT04028401: Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
Official title: Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cutibacterium Acnes Infection
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: Number of patients in each group with a positive Cutibacterium acnes sample at the dermis.
timeFrame: Day 0
Secondary outcomes:
measure: Average number of positive intraoperative Cutibacterium acnes samples
timeFrame: Day 0
measure: 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
timeFrame: Day 0
measure: Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups
timeFrame: 2 years
measure: Phylotype
timeFrame: Day 0
measure: Cutibacterium acnes strains
timeFrame: Day 0
measure: Antibiotic resistance
timeFrame: Day 0
measure: Evaluation of the skin tolerance of the topical application from the skin tolerance scale (irritation, erythema and desquamation), at the time of inclusion and at D0
timeFrame: Day 0
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: CHU de Brest
city: Limoges
country: France
facility: CHU de Limoges
city: Nantes
country: France
facility: CHU de Nantes
city: Rennes
country: France
facility: CHU de Rennes
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: Nantes University Hospital
name: Stéphane CORVEC
role: PRINCIPAL_INVESTIGATOR
References: