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SWHSI-2 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

After an operation, most wounds are closed using stiches or staples. Some wounds cannot be closed in this way and are left open. Sometimes wounds that have been closed may open up again. These “open” wounds are usually left to heal, over time, from the bottom up rather than attempting to close them again by some other means.

The most common treatment for these wounds is plain dressings. Negative Pressure Wound Therapy (NPWT) is a relatively new treatment for open surgical wounds. It uses a small machine to apply gentle suction to a wound through a special dressing. This removes wound fluid, may keep the wound clean and may help with healing. Use of NPWT has become more common and is used in around one third of people with open surgical wounds. It is not known which of these is the most effective treatment for surgical wounds healing by secondary intention.

The SWHSI-2 Trial will compare NPWT with normal dressings to see if it makes any difference to how quickly these open wounds heal. This will be a multi-centre randomised controlled trial where patients will receive one of these treatments. The study aims to randomise 696 participants, 348 to NPWT and 348 to usual care. The primary outcome is time to wound healing in days since randomisation. The associated costs of these treatment to the NHS will also be evaluated.

The study is being run by the Hull and East Yorkshire Hospitals NHS Trust (HEY) and the University of York, with funding from the National Institute for Health Research Health Technology Assessment Programme (Ref:17/42/94). Professor Ian Chetter at HEY is the Chief Investigator. 

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Funding

Funder (s): NIHR HTA 
Start Date: November 2018
End Date:  October 2022

Members

Internal Staff:

External Collaborators:

  • Ian Chetter, Hull and East Yorkshire Hospitals NHS Trust/HYMS
  • Karen Armstrong-Lamb, Leeds Community NHS Trust
  • Nikki Stubbs, Leeds Community NHS Trust
  • Jane Blazeby, University of Bristol
  • Rhiannon Macefield, University of Bristol
  • Jo Dumville, University of Manchester
  • Eileen Henderson, Hull and East Yorkshire Hospitals NHS Trust
  • Angela Oswald, Hull and East Yorkshire Hospitals NHS Trust
  • Matthew Lee, University of Sheffield
  • Thomas Pinkney, University Hospitals of Birmingham NHS Foundation Trust
  • Stephen Dixon, PPI representative

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