Surgical Wounds Healing By Secondary Intention - 2
Research type
Research Study
Full title
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)
IRAS ID
258802
Contact name
Ian Chetter
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
ISRCTN Number
ISRCTN26277546
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Research Summary
After an operation, most wounds are closed using stitches 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.\n\nThe most common treatment for these wounds is plain dressings. Another type of treatment is Negative Pressure Wound Therapy (NPWT) which is a relatively new treatment for open surgical wounds. It uses a small machine to apply suction to a wound through a special dressing. 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 (NPWT or wound dressings) is the most effective treatment for surgical wounds healing by secondary intention and which treatment is best value for money. The SWHSI-2 Trial will therefore compare NPWT to normal wound dressings to see if it makes any difference to how quickly these open wounds heal.\n\nPatients aged 18 years or older, with a surgical wound healing by secondary intention, will be invited to take part. Patients who agree to take part will receive one of the two treatments, selected at random using a computer system. We will compare what happens to the two groups over 12 months including: how long it takes peoples’ wounds to heal; other important events such as number of infections, hospital admissions and further operations; and how much both treatments cost.\n
Summary of Results
The SWHSI-2 Trial recruited 686 patients, who were equally and randomly assigned to receive either negative pressure wound therapy (NPWT) or usual care (standard dressings without NPWT). The study aimed to find out if negative pressure wound therapy healed open surgical wounds quicker than standard wound dressings and was good value for money to the NHS.
For a year we collected information from participants on wound healing, wound treatments, health outcomes such as whether the wound had become infected, wound pain and participants quality of life.
We found:
• No clear evidence that NPWT reduced the time it took for wounds to heal compared to standard wound care.
• The chances of wound infection, use of antibiotics, return to hospital or need for further surgery were similar for both treatments.
• NPWT was more expensive than standard dressings and so was unlikely to be a good use of healthcare resources.
• Most of the participants recruited into the study had wounds on their feet or legs and so the results may be more relevant to wounds in these locations, compared to wounds elsewhere on the body.The results of this study mean that patients and doctors will be able to make more informed decisions about which dressing to use for these wounds.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0054
Date of REC Opinion
8 Apr 2019
REC opinion
Further Information Favourable Opinion