Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 % benzoyl peroxide topical treatment | Experimental | Application of 5% benzoyl peroxide |
|
| No topical treatment | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% benzoyl peroxide | Drug | Application of 5% benzoyl peroxide during 5 days before the procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients in each group with a positive Cutibacterium acnes sample at the dermis. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Average number of positive intraoperative Cutibacterium acnes samples | samples taken at he cutaneous level before and after cutaneous antisepsis of the operating area before incision, fat and capsular. | Day 0 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphane CORVEC | Contact | 0240083955 | +33 | stephane.corvec@chu-nantes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Stéphane CORVEC | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Recruiting | Angers | 49933 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 0 |
| Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups | 2 years |
| Phylotype | Determination of phylotype by 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 | Day 0 |
| Cutibacterium acnes strains | Comparison of Cutibacterium acnes strains by molecular biology | Day 0 |
| Antibiotic resistance | Day 0 |
| 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 | skin tolerance scale evaluates local tolerance (absent: 0, light:1, moderate: 2 severe:3), erythema (absent:0, light:1, moderate:2, severe:3, very severe:4) and desquamation (absent: 0, light: 1, moderate: 2, severe: 3, very severe: 4) | Day 0 |
| CHU de Brest | Recruiting | Brest | 29609 | France |
|
| CHU de Limoges | Recruiting | Limoges | 87000 | France |
|
| CHU de Nantes | Recruiting | Nantes | 44093 | France |
|
| CHU de Rennes | Recruiting | Rennes | 35000 | France |
|
| CHU de Tours | Recruiting | Tours | 37170 | France |
|
| ID | Term |
|---|---|
| D001585 | Benzoyl Peroxide |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided