The ROSSINI-Platform Trial: A basket factorial multi-arm multi-stage (MAMS) platform randomised controlled trial (RCT) to evaluate the use of multiple interventions to reduce surgical site infection SSI across several types of surgery
The ROSSINI-Platform study aims to find the best ways to prevent wound infections after surgery. These infections can cause pain and slow down recovery. We're testing several methods, already used safely in some hospitals, across six types of operations including caesarean sections, heart surgery, and brain surgery. We want to see which methods effectively reduce infection rates within 30 days, improve quality of life, and offer good value. Adults having these surgeries at participating NHS hospitals might be invited to join. If you take part, you'll receive your planned surgery, possibly with an extra infection-prevention step. We'll then follow up by phone or email to check your recovery.
At a glance
What is this study about?
When you have surgery, there's a risk of getting an infection in the wound afterwards. These 'surgical site infections' can be painful, make you stay in hospital longer, and sometimes lead to more serious problems. Currently, advice on preventing these infections can be quite general, but different types of operations might need different approaches.
The ROSSINI-Platform study aims to get specific. We're looking to find out which particular infection-prevention methods work best for different kinds of surgery. This study will focus on six different surgical areas: vascular groin surgery (in the upper leg/groin area), lower limb amputation, breast surgery, heart surgery, caesarean sections, and brain surgery. We'll be testing several methods that are already used safely in some hospitals, to see if they really make a difference in preventing infections.
Ultimately, the goal is to improve how we prevent infections, which could lead to better outcomes for patients, quicker recoveries, and ensure our fantastic NHS resources are used effectively. This isn't about new, untested treatments; it's about understanding which existing, safe methods are most effective for you.
Key takeaways
- Aims to find best ways to prevent wound infections after surgery.
- Tests existing, safe methods in 6 types of operations.
- Participation involves minor changes to wound care, not the surgery itself.
- Follow-up is mostly by phone/email for up to 3 months.
- No higher risk than standard medical care.
- Helps improve care for future patients.
Who may be eligible?
You might be able to take part if you are an adult, aged 18 or older, who is having one of the specific types of surgery included in the study at an NHS hospital that is participating. These surgeries include certain operations on the blood vessels in your groin or for limb amputation, breast surgery, heart surgery, caesarean sections, or brain surgery (neurosurgery).
It's important that you (or someone supporting you) can be contacted by email or phone for follow-up questions after your operation. You also need to be able to understand what it means to take part and agree to it. If for any reason you temporarily can't give your consent, a close family member or a representative might be able to do this for you.
You won't be able to join this particular study if you've already taken part in any part of the ROSSINI-Platform study in the last 90 days.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you having one of these surgeries: vascular groin, limb amputation, breast, heart, caesarean section, or brain surgery?
- Is your surgery happening at an NHS hospital involved in this study?
- Can you be contacted by phone or email for follow-up after your operation?
- Have you NOT taken part in this specific study (ROSSINI-Platform) in the last 90 days?
What does participation involve?
If you decide to take part in the study, you'll have your surgery as planned. However, you might also receive one or more extra steps designed to prevent infection, chosen specifically for your type of operation. These extra steps could involve slight changes in how your wound is cleaned, how dressings are applied, or particular ways surgical tools are used. These are all methods already safely used in other hospitals.
You'll be randomly assigned to receive some of these extra steps or not, similar to a lottery, to make sure the results are fair. After your operation, we'll follow up with you for up to 30 days to check for any signs of infection. We'll also monitor things like your quality of life for up to 90 days. This follow-up will mostly be done over the phone or by email, and we'll also look at your hospital notes. There are no extra trips to the hospital just for the study.
Potential risks and benefits
Locations (1)
- -Unverified-, England
Common questions
What is a surgical site infection?
It's when your wound becomes infected after an operation, which can cause pain and delay your recovery.
Are the methods being tested new or experimental?
No, all the methods are already used safely in some hospitals; this study is just finding out which ones work best.
Will taking part change my main surgery?
Your surgery will go ahead as planned. The study involves small changes to how wounds are managed, not to the surgery itself.
How long will I be involved in the study?
We will check for infection for up to 30 days after your surgery and monitor your recovery for up to 90 days after your operation.
Who is paying for this study?
The study is funded by the National Institute for Health and Care Research (UK).
How to find out more
- ROSSINI- Platform Trial Team
Always speak to your GP or specialist before deciding to take part in a study.
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