VAC Therapy for Pressure Ulcers: Value of Information Analysis and Feasibility Study

Lead Research Organisation: University of York
Department Name: Health Science

Abstract

Difficult to heal wounds like pressure ulcers reduce quality of life and are costly to manage. Topical negative pressure (TNP) therapy is a treatment for such wounds which involves the application of a suction force to the wound via a dressing.

TNP therapy is widely used in the NHS, yet there is no valid research evidence to support its use. This is not the same as saying TNP therapy is ineffective — just that research evidence is lacking.

Despite this lack of evidence it is too premature to initiate a large randomised trial (the best way of evaluating a treatment) as more information is required about how feasible such a trial is and how it should be designed.

We are conducting preliminary work to investigate whether funding a large trial of TNP therapy is likely to offer good value for money and what treatment(s) we should compare TNP therapy with. Once these questions are answered we will do a pilot trial. This will determine whether a large trial is feasible (i.e. are there sufficient numbers of eligible patients?). Our study will ensure that any future trial it is more likely to answer the questions is TNP therapy is clinically and cost-effective?

Technical Summary

Pressure ulcers are a common complication of acute illness and immobility, particularly in older people. Deep (full thickness) pressure ulcers are difficult to heal and keep clean. Vacuum Assisted Closure (VAC) Therapy is commonly used in the NHS for complex and non-healing wounds such as deep pressure ulcers and costs the NHS several million pounds per year. Despite the widespread use of VAC there are only 6 small, poor quality randomised trials and none of these compare VAC with a UK-relevant comparator. We propose preliminary work to ascertain whether investment in a future RCT of VAC for pressure ulcers would represent good value for money and would be feasible. The study comprises consultation with clinical decision makers to identify the most relevant comparator; evidence synthesis, cost effectiveness modelling; a value of information analysis and a pilot study.
 
Guideline Title Pressure ulcer management: the prevention and management of pressure ulcers in primary and secondary care
Description Citation in NICE pressure ulcer guideline
Geographic Reach National 
Policy Influence Type Citation in clinical guidelines
 
Description A pragmatic multicentre randomised controlled trial to assess the clinical and cost effectiveness of negative pressure wound therapy versus usual care for surgical wounds healing by secondary intention (SWHSI 2)
Amount £1,631,171 (GBP)
Funding ID HTA/17/42/94 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 11/2018 
End 10/2022
 
Description HTA Programme
Amount £1,034,528 (GBP)
Funding ID HTA 07/60/26 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 07/2009 
End 09/2014
 
Description NIHR Programme Grant for Applied Research
Amount £2,000,000 (GBP)
Funding ID RP-PG-0609-10171 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 06/2011 
End 05/2016
 
Description NIHR Programme Grants for Applied Research:
Amount £1,844,787 (GBP)
Funding ID RP-PG-0407-10428 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 07/2008 
End 06/2014
 
Description Collaboration with Prof Ian Chetter on further research on VAC (now known as Negative Pressure Wound Therapy, NPWT) 
Organisation Hull and East Yorkshire Hospitals NHS Trust
Country United Kingdom 
Sector Public 
PI Contribution New collaborative research led to an NIHR Programme Grant for Applied Research, studying, in part, the effectiveness of NPWT
Collaborator Contribution Collaborative research.
Impact An NIHR Programme grant and associated papers - these will be reported by the Chief Investigator, Prof Ian Chetter (final report just being completed).
Start Year 2010