Case study: WOLLF: Wound Management Of Open Lower Limb
As a direct result of the findings, NICE clinical guidelines for the assessment and management of complex fractures will be updated.
WOLLF impact case study
- July 2012 - December 2015
- NIHR Clinical Research Network supported the recruitment of 460 patients across 24 major trauma hopsitals in England
- Funded by the NIHR Health Technology Assessment Programme
- Supported by the NIHR Oxford Biomedical Research Centre and the NIHR Collaboration for Leadership in Applied Health Research and Care Oxford
- Chief Investigator: Professor Matt Costa, Professor of Orthopaedic Trauma Surgery at the University of Oxford and Honorary Consultant Trauma Surgeon at the John Radcliffe Hospital, Oxford
In 2012, NHS England facilitated the establishment of regional Major Trauma Networks across England. 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 WOLLF trial was 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 Injuries and Emergencies clinical specialty within the NIHR Clinical Research Network (CRN) 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.
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.
Outcomes and findings
The findings of the trial, which have been published in the The Journal of the American Medical Association, showed that there was no statistically significant difference in the self-rated disability between NPWT or standard wound dressing at 12 months. This evidence does not support NPWT as a treatment for severe open fractures.
Value to the NHS
It is now anticipated that clinical guidelines will change in the UK 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 Chris Moran, National Clinical Director for Trauma for NHS England:
“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.”
Professor Matt Costa, Chief Investigator; Professor of Orthopaedic Trauma Surgery at the University of Oxford; and NIHR CRN National Specialty Lead for Injuries and Emergencies:
“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.
“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.”