E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cutibacterium acnes infection in shoulder arthroplasty with males |
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E.1.1.1 | Medical condition in easily understood language |
Cutibacterium acnes infection in shoulder arthroplasty with males |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Evaluer l'efficacité de l'application quotidienne, pendant les 5 jours qui précèdent l’intervention, d'un topique de peroxyde de benzoyle 5 % au niveau de la zone d'incision cutanée opératoire, sur la diminution de charge bactérienne à Cutibacterium acnes au niveau du derme de la voie d'abord d'une arthroplastie d'épaule chez l'homme. |
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E.2.2 | Secondary objectives of the trial |
● 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. |
●Evaluer, dans le cadre d'une arthroplastie d'épaule chez l'homme, l’efficacité de l'application de peroxyde de benzoyle 5 %, sur la zone d'incision cutanée, pendant les 5 jours qui précèdent l’intervention, sur : o Evaluer la charge bactérienne à Cutibacterium acnes au niveau cutané, graisseux et capsulaire sur la voie d’abord; o Evaluer l'incidence des infections à Cutibacterium acnes dans les 2 ans suivant la chirurgie. ● Evaluer, dans le cadre d'une arthroplastie d'épaule chez l'homme, l’efficacité de la povidone iodée alcoolique 5 % (antiseptie de la zone opératoire au bloc) sur la charge bactérienne cutanée à Cutibacterium acnes ; ● Caractériser sur le plan phylotypique et génotypique les différentes souches de Cutibacterium acnes retrouvées ; ● Evaluer la tolérance cutanée de l'application du gel de peroxyde de benzoyle 5 %. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day of the intervention (Day 0) |
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E.5.2 | 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
● Day 0 ● Day 0 ● 2 years ● Day 0 ● Day 0 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |