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临床试验/ISRCTN33993149
ISRCTN33993149已完成未知

Fluid Lavage of Open Wounds (FLOW): a multicentre, blinded, factorial trial comparing alternative irrigating solutions and pressures in patients with open fractures

McMaster University (Canada)0 个研究点目标入组 2,280 人开始时间: 2009年7月13日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
2,280

研究概览

简要总结

  1. 2010 protocol results in: https://www.ncbi.nlm.nih.gov/pubmed/20459600 (added 10/04/2019) 2. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26448371 (added 10/04/2019) 3. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30579406 (added 10/04/2019)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Men or women who are 18 years of age or older
  • 2. Fracture of any extremity with complete radiographs
  • 3. Open fractures (Gustilo-Anderson Types I-IIIB)
  • 4. Fracture requiring operative fixation
  • 5. Provision of informed consent

排除标准

  • 1. Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC)
  • 2. Known allergy to detergents or castile soap ingredients
  • 3. Previous wound infection or history of osteomyelitis in the injured extremity
  • 4. Previous fracture with retained hardware in injured extremity that will interfere with new implant fixation
  • 5. Surgical delay to operative wound management greater than 24 hours from hospital admission
  • 6. Use of immunosuppressive medication within 6 months
  • 7. Immunological deficient disease conditions (e.g., human immunodeficiency virus [HIV])
  • 8. Fracture of the hand (metacarpals and phalanges)
  • 9. Fracture of the toes (phalanges)
  • 10. Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
  • 11. Previous randomisation in this study or a competing study
  • 12. Patient is a prisoner or is at high risk of incarceration during the follow-up period

研究者

发起方
McMaster University (Canada)

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