2024-515584-56-00招募中3 期
Optimization of skin preparation to reduce Cutibacterium acnes colonization in superficial and deep samples during prosthetic shoulder surgery in male patients (OPRICA)
Centre Hospitalier Universitaire De Nantes6 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年10月21日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 6
- 主要终点
- Number of patients in each group (interventional: benzoyl peroxide 5% for 5 days or control) with a positive Cutibacterium acnes sample at the dermis.
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient with arthroplasty for resumption of previous shoulder surgery or failure of arthroplasty
- •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
- •patient with an infectious site
- •Major under guardianship
- •Patient under the protection of justice
- •Patient not covered by social security
- •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, hypersensitivity to benzoyl peroxide)
结局指标
主要结局
Number of patients in each group (interventional: benzoyl peroxide 5% for 5 days or control) with a positive Cutibacterium acnes sample at the dermis.
Number of patients in each group (interventional: benzoyl peroxide 5% for 5 days or control) with a positive Cutibacterium acnes sample at the dermis.
次要结局
- 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
研究者
Stéphane CORVEC
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (6)
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