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
- 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
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