The University of Nottingham is collaborating with the University of Birmingham on a £10m funded trial which will recruit 26,000 patients across country to reduce post-surgery infections.
The largest surgical trial ever funded in the UK is set to open, which will see 26,000 patients recruited to test interventions that will make future operations safer.
More than £10m of funding from the National Institute for Health and Care Research (NIHR) has been awarded to the University of Birmingham to run an ambitious trial which aims to recruit 26,000 patients from 100 sites across the UK in the next five years.
ROSSINI-Platform is a large multi-arm, multi-stage platform trial, led by Professor Thomas Pinkney and the Birmingham Clinical Trials Unit, that will help experts understand how to reduce wound infections that can occur following operations.
Wound infections, also referred to as Surgical Site Infections (SSI), are the commonest complication after surgery and affect up to one in four patients undergoing surgery each year. These infections carry an estimated cost to the NHS of at least £700m each year.
Professor Judith Tanner, from the School of Health Sciences at the University of Nottingham, Melissa Rochon from Guy's and St Thomas' NHS Foundation Trust and Isla Health, have developed a secure digital monitoring platform where patients have photographs and information about their wounds assessed regularly when they are recovering at home after surgery. The digital monitoring platform will be used to assess the wounds of all the 26,000 patients from 100 hospitals taking part in this study.
Around a quarter of patients who have surgery develop an infection in their wound. Some infected wounds will clear up fairly quickly, but others can take months or even years to heal, causing patients and their families unnecessary pain and distress. This trial will definitively identify interventions that will reduce or prevent surgical wound infections."
Professor Thomas Pinkney from the School of Health Sciences at the University of Birmingham, and Chief Investigator of the ROSSINI-Platform trial said: "An adult living in the UK will have an average of four operations during their lifetime. Up to a quarter of operations may result in a surgical site infection (SSI) – a post-operative infection of the wound – which can have significant negative impacts on patient recovery.
"We know that infections at different operation sites can cause different types of challenges. For example, an infection following a caesarean section can impact on the mothers' ability to bond with their newborn. An infection following amputation could mean that the patient is no longer suitable to be fitted for a prosthetic, meaning they might become a wheelchair user.
"Post pandemic the waiting lists for surgeries are higher than ever, so an evidence-based approach to improving recovery times and reducing preventable complications and their associated risk of readmissions has never been more necessary."
ROSSINI-Platform will look at various interventions to reduce the rates of surgical site infection, and the design of the trial will enable the team to focus on those that show evidence of benefit.
In total, 18 interventions are being assessed in the trial, with examples including:
- using state-of-the-art wound cleaning solutions during surgery
- using special wound dressings after surgery,
- applying antibiotics differently during surgery,
- changing gloves and instruments at certain points during surgery,
- waxing or epilation around the surgical site
In addition, the trial will test these interventions across multiple operation types areas such as heart surgery, brain surgery, caesarean section and leg amputation, to find what works best to reduce infection in each setting.
SSIs are a significant problem for the NHS, due to increased treatment costs and resource usage both in hospital and in the community. SSI is now the most common healthcare associated infection and costs the NHS at least £700million per year. It is therefore a priority for patients and the health service.
The trial team hope that the findings will help countries around the world to implement the most effective ways to prevent SSI following different types of common surgeries. This will help speed up recovery, get patients discharged from hospital sooner freeing up bed space, and in many countries around the world will save countless lives.
