Title: Surgical wounds healing by secondary intention: characterising and quantifying the problem and identifying effective treatments
Funder: Department of Health (England)

Abstract: There are more than six million surgical operations conducted per year in the NHS and most involve an incision.[1] The edges of most incised wounds are sutured, clipped, glued or otherwise directly held together whilst healing occurs (known as healing by ‘primary intention’) however many surgical wounds either break open or are left open to heal from the “bottom up” (called ‘secondary intention)’. [2,3] Surgical Wounds Healing by Secondary Intention (SWHSI) pose a unique management challenge; they can remain open for many months (see Annex 4.1 for patient narratives), may require a multitude of treatments, are highly susceptible to infection and may require prolonged hospitalisation and/or further operations. The management and treatment of SWHSI probably costs the NHS millions of pounds per year and they undoubtedly have a severe impact upon patients’ quality of life. Although SWHSI are common, there is a complete lack of data on their natural history and epidemiology, and which treatments are clinically and cost effective. A systematic review reported there was very poor, low quality evidence for the treatment options available for SWHSI [6] and NICE concluded that randomised controlled trials of treatments for SWHSI were a key research priority.[7] We have no knowledge of the impact of these wounds on patients and their quality of life. This research aims to establish the nature, extent, costs, outcomes, impact and current treatments of SWHSI, the clinical and cost effectiveness of treatments and the value and nature of further primary research on SWHSI. We will meet our aims through five interdependent Workstreams (Annex 4.2): WS1: is an inception cohort of incident surgical wounds healing by secondary intention from which we will collect naturalistic data on treatments used, rates of healing and adverse events, resources consumed and quality of life. In WS2 we we will establish the clinical and cost effectiveness of the treatments identified in WS2 and the literature by evidence synthesis and decision analytic modelling. In WS3 we will learn much more about the impact of surgical wounds healing by secondary intention from the patients’ perspective as well as identify desirable performance characteristics of treatments from the perspective of health care professionals whilst in WS4 we will use value of information techniques to assess whether investment in future research in this field is likely to be worthwhile, and what that research should be. WS5 will pilot the new primary research to determine feasibility. Benefits to patients should begin to flow quickly through reductions in inappropriate variations in practice and over the longer term by development of an evidence base that reflects their concerns. Benefits to the NHS in the form of knowledge about which treatments are cost effective and which should be reduced or abolished will also begin to flow over the short term. The research team unites expertise in surgery, nursing, NHS management and health services research. The team will be led by Ian Chetter, an academic vascular surgeon with a growing research reputation for randomised trials and quality of life research in vascular disease. He will be supported by a highly experienced, multidisciplinary research team with an international reputation for wounds research (particularly randomised trials and evidence synthesis). The research will be hosted by Hull and East Yorkshire Hospitals NHS Trust (HEYHT), which is committed to the generation and use of evidence in practice. The close involvement of Eileen Henderson (Assistant to Medical Director) in preparing this bid and her input over the life of the programme will ensure that there is the required strategic and organisational capacity to support the work. Importantly the programme represents a new stream of collaborative research between a new medical school (Hull York Medical School) and a centre of research excellence; Hull and York are only 39 miles apart with excellent transport links. Patient involvement, via our co-applicant John Ball, has been instrumental to the bid and is costed for the life of the work along with costs for two further patient collaborators. We have opted for a 3 rather than 5 year programme of preparatory work in order to speed the development of a future research agenda and ultimately the generation of the new knowledge required. We have kept costs to a minimum with all the new posts being either short duration, part time, or both. The new NHS posts are in data capture (three research nurses, one database manager and a data clerk) and university posts will analyse quantitative data (partial funding of a statistician, health economist and research fellow) and collect and analyse qualitative data (two research fellows for 18 months only). We have included the cost of 0.4 administrator in both the NHS and university to ensure the smooth running and coordination of the work and its finances.


Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE