Open fracture trial supports advancement of major trauma research
The findings of a clinical trial funded and supported by the NIHR has marked a step change in the way in which major trauma research is delivered in the UK, thanks to its roll out across a national Major Trauma Network.
Despite major trauma being the leading cause of death in people aged under 40, clinical research within this area has historically been difficult to undertake due to the dispersed location of patients and the nature of their injuries. This changed when NHS England facilitated the establishment of regional Major Trauma Networks across England from 2012. These networks brought patients into a smaller number of specialist major trauma centres where care could be delivered by multi-disciplinary experts.
It soon became clear to experts in the Major Trauma Network that there were many unanswered questions related to the management of patients with major trauma, including those with open fractures. Most fractures are contained within the skin, but if the skin is broken the ‘open’ fracture is at much greater risk of infection due to the broken bone being exposed to contamination from the outside environment. Wound complications associated with open fractures cause marked disability for the patient and high healthcare costs.
Negative Pressure Wound Therapy (NPWT) is an alternative dressing for open fractures which creates a partial vacuum using suction, removing blood and fluid that may collect in the wound in the process. Whilst popular with surgeons and patients, there had been little information about its effectiveness.
The NIHR-funded WOLLF (Wound Management of Open Lower Limb Fractures) trial is a randomised controlled trial comparing NPWT with standard dressings for open fractures of the lower limb.
The trial was conducted by the University of Warwick Clinical Trials Unit, University Hospitals Coventry and Warwickshire NHS Trust and the University of Oxford. Between July 2012 and December 2015, 460 patients took part across 24 major trauma hospitals representing the Major Trauma Network.
The £2.18m study was funded by the NIHR Health Technology Assessment (HTA) programme and supported by the NIHR Oxford Biomedical Research Centre and the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford.
The Injuries and Emergencies clinical specialty within the NIHR Clinical Research Network also worked with the study team to identify additional sites for the study and crucially, used their expertise in research within emergency settings to consent patients at each centre to take part in the trial. As such, the study closed to recruitment on schedule, after the Injuries and Emergencies specialty recruited the target number of patients.
Professor Matt Costa, Chief Investigator of the study and NIHR National Specialty Lead for Injuries and Emergencies, said: “Delivery of the WOLLF trial wouldn’t have been possible without the expertise of NIHR research nurses in taking consent under such challenging circumstances and within difficult environments.
“It is a great example of how the Major Trauma Network and the Injuries and Emergencies clinical research teams worked together to deliver a very complex trial.”
Dominic Burton, a 50 year old demonstration car driver from Banbury, was enrolled onto the WOLLF trial in 2013 after sustaining an injury to his right leg following a forklift truck accident at work. The ambulance crew made the decision to admit him to the John Radcliffe Hospital in Oxford, a major trauma centre serving the Thames Valley region. There, he was asked about whether he would be willing to take part in the trial.
Explaining his decision to consent, Dominic said: “Everything was explained in terms of what the trial was aiming to do and what it would focus on.
“I knew I probably wouldn’t be coming home in the next couple of days and was feeling a bit low at that point, and I thought about how the trial might help someone else who found themselves in the same position as me, so I said it was absolutely fine.”
Dominic was given a standard dressing and was in hospital for just over three weeks before he was discharged. He experienced benefits from the trial that he did not initially expect.
“It gave me more of a focus. Being on the trial heightened my interest, so I learned more about the type of injury I had and the long-term effects of it.”
Patients taking part in the trial were required to complete questionnaires during the year after sustaining their injuries, to allow the research team to assess their level of disability, rate of infection and quality of life. This aspect of the research supported Dominic’s 18-month recovery in additional ways.
“By asking about my personal wellbeing in addition to my physical injury, the questionnaire made me think a bit differently.
“I don’t think I would have even considered some of the questions had I not been asked them as part of the trial.”
The findings of the trial, which were recently published in the The Journal of the American Medical Association, showed that there was no evidence that NPWT reduced patients' disability after 12 months, and therefore the research doesn’t support the treatment for severe open fractures.
Professor Chris Moran, National Clinical Director for Trauma for NHS England, said: “Major trauma networks have greatly improved the care of patients throughout the country with an extra 600 lives saved last year alone.
“The development has also provided the opportunity to produce world-class trauma research in the UK and the results of these studies will benefit many future patients, not just by saving life but also by reducing disability and allowing patients a better recovery.”
It is now anticipated that clinical guidelines will change in the UK later this year to reflect the results of the trial. Given that NPWT dressings and the vacuum machines are considerably more expensive than traditional wound dressings (with NPWT costing on average £84 compared with approximately £4 for standard dressings), the findings are also likely to lead to considerable cost-savings for the NHS.
It is also expected that by making use of the Major Trauma Network’s concentrated resources and clinical expertise in a smaller number of hospitals, WOLLF will support a growing demand for major trauma research in the UK, which will ultimately improve the care and treatment of patients with such severe injuries.
Professor Costa concluded: “Notwithstanding the significant impact of the trial, WOLLF paves the way for how major trauma research will be delivered in the future, by demonstrating that with the benefit of the Major Trauma Network researchers can undertake complicated major trauma trials in the UK.”
Professor Hywel Williams, Director of the NIHR HTA Programme, said: “Sometimes, research funded by the NIHR HTA programme shows that things that are creeping into practice do not work. The WOLLF study is an excellent example of such a study - which will now inform guidelines on stopping the use of negative wound pressure for open lower limb fractures. Stopping things is never easy, but it will free up NHS resources that can be used on things that do help patients.
“In addition, the WOLLF study has shown how it is possible to conduct research under the challenging conditions of major trauma at a national scale with the assistance of the Major Trauma Network."
More information on the study is available on the NIHR Journals Library.