EUCTR2019-001419-21-FR进行中(未招募)1 期
Optimization of skin preparation to reduce Cutibacterium acnes colonization in superficial and deep samples during prosthetic shoulder surgery in male patients - OPRICA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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 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
研究者
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