Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection.
This study is looking at a new treatment called D-PLEX. Its main goal is to find out if D-PLEX can help prevent infections that can happen in the cut (incision) after abdominal (tummy) surgery. We want to see if combining D-PLEX with the standard care patients already receive works better than standard care alone to stop these infections. The study will especially focus on people who have had a longer surgical cut. By comparing these two groups, doctors hope to learn if D-PLEX is both safe and effective in reducing the risk of wound infections, helping patients recover more smoothly after surgery.
At a glance
What is this study about?
Imagine you're having an operation on your tummy. After the surgery, the cut your surgeon made (they call this an incision) needs to heal. Sometimes, this can become infected, which can cause problems and slow down your recovery. This study is designed to find a better way to prevent these infections from happening in the first place.
Researchers are testing a new treatment called D-PLEX. They want to see if using D-PLEX alongside the usual care you'd get after surgery can help stop infections in the wound. To do this, they're comparing two groups of people: one group will receive D-PLEX plus their standard care, and the other group will receive just standard care. The doctors won't know which treatment each person is getting, and neither will the patients, to make sure the results are fair and unbiased.
The main thing the study will measure is how many people in each group get an infection in their surgical cut within 30 days of their surgery. They're especially interested in people who have had a longer surgical cut, usually longer than 20 centimetres (about 8 inches). By carefully comparing the infection rates, the study aims to determine if D-PLEX is a safe and effective way to reduce the risk of winding up with an infection after tummy surgery.
Key takeaways
- This study is testing a new treatment called D-PLEX for preventing infections after abdominal surgery.
- It compares D-PLEX plus standard care to standard care alone.
- The study is 'double-blind,' meaning neither patients nor doctors know who gets which treatment.
- It focuses on preventing infections in longer surgical cuts (>20cm) within 30 days of surgery.
- Participants will be closely monitored for 30-60 days after their operation.
Who may be eligible?
To join this study, participants must be at least 18 years old. Both men and women can take part. The study is particularly looking for people who are planning to have abdominal (tummy) surgery where the cut is expected to be quite long, specifically 20 centimetres or more. Your surgical team will be able to tell you if your planned surgery meets this requirement.
There will also be other specific health requirements and medical conditions that might mean you can't join the study, even if you meet the age and incision length criteria. Your study doctor will review your full medical history to make sure the study is a safe option for you.
It's important that you are able to understand and be willing to follow all the study instructions and attend all scheduled appointments. Your doctor will discuss all the detailed requirements with you to see if you're a good fit for this research.
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 scheduled for abdominal (tummy) surgery?
- Is your expected surgical cut going to be 20 centimetres (about 8 inches) or longer?
- Are you able to attend all follow-up appointments after your surgery?
- Are you willing to have an experimental treatment alongside your usual care?
What does participation involve?
If you decide to take part in this study, you would receive the study treatment, D-PLEX, at the time of your abdominal surgery, along with your usual medical care. Some participants will receive a placebo (a dummy treatment) instead of D-PLEX, along with their usual care – neither you nor your doctors will know which you are receiving.
After your surgery, you’ll be carefully monitored for 30 days to check for any signs of infection in your surgical wound. This will involve regular check-ups and assessments by the study team. You'll need to attend specific appointments so the doctors can closely monitor your recovery and how your wound is healing. The study will also track your health for up to 60 days in total to see how you are doing overall. The study team will explain exactly when and where these visits will take place.
Potential risks and benefits
Locations (7)
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- —UnverifiedItaly
- —UnverifiedRomania
Common questions
What is D-PLEX?
D-PLEX is a new treatment being tested to see if it can help prevent infections after tummy surgery.
Will I know if I'm getting D-PLEX or the usual care?
No, neither you nor your doctors will know which treatment you are receiving. This helps make the study results fair.
How long will I be in the study?
You'll be closely monitored for 30 days after your surgery, and your health will be tracked for up to 60 days in total.
What kind of infections are you trying to prevent?
We are trying to prevent infections specifically in the cut (incision) location after your tummy surgery.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without it affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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