Optimization of Skin Preparation to Reduce Cutibacterium Acnes Colonization in Superficial and Deep Samples During Prosthetic Shoulder Surgery in Male Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 6
- 主要终点
- Number of patients in each group with a positive Cutibacterium acnes sample at the dermis.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 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
- •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
研究组 & 干预措施
5 % benzoyl peroxide topical treatment
Application of 5% benzoyl peroxide
干预措施: 5% benzoyl peroxide (Drug)
结局指标
主要结局
Number of patients in each group with a positive Cutibacterium acnes sample at the dermis.
时间窗: Day 0
次要结局
- 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(Day 0)
- Incidence of Cutibacterium acnes shoulder prosthesis infections up to 2 years after shoulder prosthesis implantation in both study groups(2 years)
- Phylotype(Day 0)
- Cutibacterium acnes strains(Day 0)
- Average number of positive intraoperative Cutibacterium acnes samples(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(Day 0)