Fluid Lavage of Open Wounds (FLOW): A Multicenter, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients with Open Fractures
Annual rept. 30 Sep 2012-29 Sep 2013
GREENVILLE HOSPITAL SYSTEM UNIV MEDICAL CENTER GREENVILLE S C
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Thorough irrigation and debridement is the most important initial step in preventing infection in open fractures. However, there is little clinical evidence as to the best irrigation methods and additives. This is a blinded patients and outcome assessors, 2x3 factorial design randomized trial to investigate whether irrigation solution soap vs. saline solution, or irrigation pressure high vs. low vs. gravity flow will decrease the reoperation rate among patients with open fractures. The hypotheses are that a soap solution will result in fewer reoperations in patients with open fractures compared to saline solution, and that low-pressure irrigation and gravity flow will result in fewer reoperations than high-pressure irrigation. Study follow-up will be for one year postinjury. The primary outcome is reoperation for infection, wound healing or fracture healing problem. Secondary outcomes include health related quality of life. Enrollment was completed on September 30, 2013, with 2545 patients enrolled internationally, and 149 covered under this grant.
- Medicine and Medical Research