Abstract
Purpose: The optimal choice of irrigating solution or irrigating pressure in the initial management of open fracture wounds remains controversial. FLOW compared the effect of castile soap versus normal saline, and low versus high pressure pulsatile lavage on one year re-operation rates in patients with open fracture wounds.
Method: We conducted a multicenter, blinded, two-by-two factorial, pilot randomized trial of 111 patients with open fracture wounds receiving either castile soap solution or normal saline and either high or low pressure pulsatile lavage. The primary outcome, reoperation within one year, included infections, wound healing problems, and nonunions. Secondary outcomes included all operative and non-operative infections, wound healing problems, nonunion and functional outcomes. We followed the intention to treat principle.
Results: Eighty-nine patients (80.2%) completed the 12-month follow-up. As anticipated in this small-sample-size pilot study, results were compatible with substantial benefit and substantial harm: the hazard ratio (HR) for reoperation with castile soap was 0.77, 95% CI 0.35 to 1.69, p=0.52; with low pressure lavage, the hazard ratio for the risk of reoperation was 0.56, 95% CI 0.25 to 1.27, p=0.17. Secondary outcomes showed a significant relative risk reduction for nonunion of 63% in favour of castile soap (p=0.036), and a trend for a relative risk reduction for nonunion of 44% in favour of low pressure lavage (p=0.22).
Conclusion: The FLOW pilot study suggests the possibility of an important reduction in reoperation rates for both castile soap and low pressure pulsatile lavage. Our findings provide compelling rationale for continued investigation in a pivotal FLOW trial of 2280 patients.
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