RecruitingPHASE3INTERVENTIONAL

The MANTRA Trial (MANdibular TRauma and Antibiotic Use)

The MANTRA trial is investigating the best approach to using antibiotics after surgery for a broken jaw. Many people get antibiotics after this surgery to prevent infection, but doctors aren't sure if they're always necessary, or which type is best. Unnecessary antibiotics can lead to problems like antibiotic resistance. This study will compare three groups: one getting no antibiotics after surgery, one getting a short course of intravenous antibiotics, and a third group getting intravenous antibiotics followed by a 5-day course of antibiotic tablets. We want to see if we can reduce antibiotic use safely, prevent infections, and help manage healthcare costs in the NHS.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

East Lancashire Hospitals NHS Trust

Enrolment target

2,841

Start

06 Dec 2024

Estimated completion

31 Dec 2027

Mandible Fracture Post-operative Antibiotics

What is this study about?

When someone breaks their jaw, surgery is often needed to fix it. Because the mouth contains many germs, there's a risk of infection after this surgery. To prevent this, doctors usually give antibiotics. However, doctors in the UK don't always agree on whether antibiotics are truly needed, or what the best way to give them is. Giving too many antibiotics can cause problems, such as making bacteria resistant to antibiotics, which means the antibiotics might not work when they're really needed in the future. It can also cause side effects like an upset stomach.

The MANTRA trial aims to find the clearest answer to this question. We want to see if it's safe and effective to give fewer or no antibiotics after jaw surgery, compared to current common practice. This study will involve many NHS hospitals and will compare three different ways of giving antibiotics after jaw surgery. All patients in the study will receive one dose of antibiotics through a drip just before their surgery to help prevent infection during the operation itself.

After surgery, patients will be placed into one of three groups by chance: one group will not receive any more antibiotics, another will receive two more doses of antibiotics through a drip, and a third group will receive two more doses through a drip followed by a five-day course of antibiotic tablets to take at home. By comparing these groups, we hope to find the best way to prevent infections after jaw surgery, while also being smart about how we use antibiotics.

Key takeaways

The MANTRA trial is about finding the best way to prevent infections after jaw surgery.
It aims to see if we can safely use fewer antibiotics.
All participants receive antibiotics before surgery.
After surgery, you'll be in one of three groups, with different antibiotic plans.
This research could help improve care for many future patients.
Your participation is voluntary and you can leave at any time.

Who may be eligible?

You might be able to take part in this study if you are 18 years old or older and have broken your jaw in a way that requires surgery to fix it with small metal plates. You must also be able to understand the study and give your permission to take part.

However, you won't be able to join the study if your jaw break is only in a specific area called the mandibular condyle, or if the break is already infected. You also can't take part if you have a weakened immune system (for example, if you've had an organ transplant or have certain blood conditions or HIV/AIDS), or if your jaw break was caused by something like cancer or certain medications, rather than an injury.

Additionally, if your broken jaw has caused an open wound through the skin, or if you have other serious injuries or infections that require you to have ongoing antibiotics for other reasons, you won't be able to participate. Lastly, if you are allergic to the main antibiotics used in this study, unfortunately, you won't be able to join.

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 surgery for a broken jaw?
Is your jaw fracture NOT already infected?
Do you NOT have a severely weakened immune system?
Are you NOT allergic to common antibiotics like co-amoxiclav?
Can you understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll still have your jaw surgery as planned. Just before your surgery, you'll receive one dose of antibiotics through a drip. After your surgery, a computer will randomly place you into one of three groups: one group won't receive any more antibiotics, another will receive two more doses of antibiotics through a drip in the hospital, and the third group will receive two more doses through a drip followed by a 5-day course of antibiotic tablets to take at home. The study will monitor how you recover and check for any infections or side effects during your hospital stay and after you go home. We'll ask you to come for follow-up appointments after your surgery, just as you normally would, and we'll keep in touch to understand how you're doing. The total time you'll be involved in the study will last until about six months after your surgery, when your last follow-up checks are completed.

Potential risks and benefits

By taking part, you could be helping us find the best way to prevent infections for future patients who break their jaw, and reduce the use of unnecessary antibiotics. You will also receive careful monitoring for any signs of infection. While there are potential benefits to medical knowledge, there's no guarantee of direct personal benefit from being in the study. There's a chance you might experience an infection, as we are exploring if fewer antibiotics are just as safe. Antibiotics themselves can also have side effects, like sickness or diarrhoea, and there's a small risk of allergic reactions. Remember, taking part is completely voluntary, and you can change your mind and withdraw from the study at any time without it affecting your medical care.

Locations (2)

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

East Lancashire Hospitals NHS Trust
Verified postcode
Blackburn, United Kingdom· Recruiting
East Lancashire Hospitals NHS Trust
Verified postcode
Blackburn, United Kingdom· Not yet recruiting

Common questions

What is the MANTRA trial about?

It's a study to find out the best way to use antibiotics after surgery for a broken jaw, to prevent infections.

Why is this study important?

It helps us understand if we can safely reduce antibiotic use, which is good for your health and fights antibiotic resistance.

Will I still get antibiotics if I join the study?

Yes, everyone gets one dose of antibiotics just before surgery. After that, what you get depends on which study group you're in.

What are the different groups in the study?

One group gets no more antibiotics, one gets two more doses through a drip, and a third gets two more doses through a drip plus 5 days of tablets.

How long will I be involved in the study?

Your involvement will include your surgery and follow-up appointments, typically lasting for about six months after your operation.

How to find out more

Panayiotis Kyzas

Panayiotis.Kyzas@elht.nhs.uk +447505402640 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.