Clinical Trial: Fluid Lavage of Open Wounds
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Fluid Lavage of Open Wounds (FLOW): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients With Open Fractures
Brief Summary: Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a common complication. There is currently little evidence as to which is the most effective way to wash out these wounds. This study is a multi-center, prospective, randomized study. The infection rates will be compared between irrigation using high pressure versus low pressure versus gravity flow, and also saline versus a soap solution as the irrigation solution. The results from this study will help to determine the best method of washing out open fractures wounds. In this study, all open wounds will be washed out using methods commonly used by orthopaedic surgeons
Detailed Summary:
Sponsor: Greenville Health System
Current Primary Outcome: Re-operation within 12 months post initial surgery to treat an infection, manage a wound healing problem, or promote fracture healing. [ Time Frame: within 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Patient function and quality of life measured by the Short Form-12 (SF-12) and the EuroQol-5D [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Greenville Health System
Dates:
Date Received: November 7, 2008
Date Started: June 2009
Date Completion:
Last Updated: February 10, 2016
Last Verified: February 2016