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