AuthorisedTherapeutic exploratory (Phase II)Interventional

Selective decontamination of the digestive tract in preventing surgical site infections in elective colorectal surgery: a randomised controlled trial (SELDDEC Trial)

This research study is called the SELDDEC Trial. It's for people who are having planned bowel surgery and are at risk of getting an infection where the surgeon makes a cut. We are testing if giving two specific antibiotics, erythromycin and neomycin, before surgery can help prevent these infections. This is a Phase II study, meaning we are exploring if this treatment works and is safe. We will be looking closely at how many people get an infection, how long they stay in hospital, and if they have any other problems after their operation. The goal is to find better ways to keep patients free from complications after bowel surgery.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

University Hospital Limerick

Enrolment target

322

Start

30 Jan 2025

Surgical site infection

What is this study about?

Imagine you're having an operation on your bowel. Even with the best care, there's always a chance of getting an infection where the surgeon makes their cut. This is called a surgical site infection, and it can slow down your recovery.

This study, called the SELDDEC Trial, is trying to find a clever way to lower that risk. It focuses on a treatment called 'selective decontamination of the digestive tract.' This isn't about cleaning your whole body; it's about using specific antibiotics to reduce certain germs in your bowel before surgery. The idea is that fewer harmful germs before the operation might mean fewer infections afterwards.

We will be giving some patients two antibiotics, erythromycin and neomycin, before their planned bowel surgery. We will then compare how many people get a surgical site infection with those who don't receive this specific antibiotic combination. We'll also be looking at other important things like how long people stay in hospital, if they have other health issues after surgery, and their overall recovery. This research is important because finding better ways to prevent infections can make a real difference to how well and quickly people recover after their operation.

Key takeaways

The study explores preventing infections after bowel surgery.
It tests specific antibiotics given before the operation.
The main goal is to reduce infections at the surgical site.
It also looks at hospital stay and other recovery issues.
Participation is for adults having planned bowel surgery.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part. The main requirement is that you are planning to have bowel surgery soon.

It's important that your surgery is a planned (elective) one, not an emergency. The study is specifically looking at people undergoing bowel operations, so if you're having a different type of surgery, this study wouldn't be suitable for you.

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 planned (elective) bowel surgery?
Are you able to take antibiotic tablets by mouth?
Do you understand that you might receive the antibiotics or not, as part of the study design?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it would involve taking two antibiotic tablets (Erythromycin and Neomycin) before your planned bowel surgery. You would continue to receive the usual care you would expect for your operation and recovery. The study team would then closely monitor you for any signs of infection or other complications after your surgery. They would collect information on how long you stay in hospital. The total duration of your participation would cover the period leading up to your surgery, during your hospital stay, and a follow-up period to check on your recovery, likely until after your surgical wound has healed and you've returned home.

Potential risks and benefits

Taking part in this study might help us discover if a new approach can reduce infections after bowel surgery, potentially benefiting future patients. However, like all medications, the antibiotics used can have side effects, which your doctor will explain. There's also no guarantee that taking these antibiotics will prevent an infection for you personally. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Ireland

Common questions

What kind of surgery is this study for?

This study is for people having planned (elective) surgery on their bowel (colorectal surgery).

What are surgical site infections?

These are infections that can happen where the surgeon makes the cut during an operation. They can make recovery slower.

Are the study antibiotics new drugs?

No, erythromycin and neomycin are established antibiotics, but this study is looking at using them in a specific way to prevent infections before bowel surgery.

Will I know if I'm getting the antibiotics?

This is a 'randomised controlled trial,' which means some participants will receive the antibiotics and others will not, to see if the antibiotics make a difference. Your study doctor will explain this in more detail.

What happens if I change my mind?

You are completely free to leave the study at any time. This won't affect the care you receive for your surgery or recovery.