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 (soapversusnormal saline) and irrigation pressure (very lowversuslowversushigh) 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 < 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.