Wound irrigation does not affect healthrelated quality of life after open fractures: Results of a randomized controlled trial

Abstract

© 2018 Sprague et al. 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 postfracture. 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 multilevel 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 \u3c 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