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临床试验/EUCTR2019-001419-21-FR
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

CHU de Nantes0 个研究点目标入组 110 人开始时间: 2019年7月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
CHU de Nantes
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

发起方
CHU de Nantes

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