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ABSTRACT: Aims
The Fluid Lavage in Open Fracture Wounds (FLOW) trial was a multicentre, blinded, randomized controlled trial that used a 2 × 3 factorial design to evaluate the effect of irrigation solution (soap versus normal saline) and irrigation pressure (very low versus low versus high) on health-related quality of life (HRQL) in patients with open fractures. In this study, we used this dataset to ascertain whether these factors affect whether HRQL returns to pre-injury levels at 12-months post-injury.Patients and methods
Participants completed the Short Form-12 (SF-12) and the EuroQol-5 Dimensions (EQ-5D) at baseline (pre-injury recall), at two and six weeks, and at three, six, nine and 12-months post-fracture. We calculated the Physical Component Score (PCS) and the Mental Component Score (MCS) of the SF-12 and the EQ-5D utility score, conducted an analysis using a multi-level generalized linear model, and compared differences between the baseline and 12-month scores.Results
We found no clinically important differences between irrigating solutions or pressures for the SF-12 PCS, SF-12 MCS and EQ-5D. Irrespective of treatment, participants had not returned to their pre-injury function at 12-months for any of the three outcomes (p < 0.001).Conclusion
Neither the composition of the irrigation solution nor irrigation pressure applied had an effect on HRQL. Irrespective of treatment, patients had not returned to their pre-injury HRQL at 12 months post-fracture. Cite this article: Bone Joint J 2018;100-B:88-94.
SUBMITTER: Sprague S
PROVIDER: S-EPMC6413805 | biostudies-literature | 2018 Jan
REPOSITORIES: biostudies-literature
Sprague S S Petrisor B B Jeray K K McKay P P Heels-Ansdell D D Schemitsch E E Liew S S Guyatt G G Walter S D SD Bhandari M M
The bone & joint journal 20180101 1
<h4>Aims</h4>The Fluid Lavage in Open Fracture Wounds (FLOW) trial was a multicentre, blinded, randomized controlled trial that used a 2 × 3 factorial design to evaluate the effect of irrigation solution (soap <i>versus</i> normal saline) and irrigation pressure (very low <i>versus</i> low <i>versus</i> high) on health-related quality of life (HRQL) in patients with open fractures. In this study, we used this dataset to ascertain whether these factors affect whether HRQL returns to pre-injury le ...[more]