RecruitingPhase IIInterventional

Using ultrasound to improve antibiotic treatment in infected burns: a feasibility study

Q: What is a 'partial-thickness' burn?

A partial-thickness burn affects the top layers of your skin, often causing blisters, redness, and pain, but it hasn't damaged all layers like a 'full-thickness' burn would.

Q: What are microbubbles?

Microbubbles are tiny gas bubbles contained in a solution. In this study, they're used with ultrasound to help deliver antibiotics more directly to the infected burn area.

Q: What is a placebo?

A placebo is a treatment that looks exactly like the real treatment but doesn't contain any active medicine. It helps researchers compare the effects of the new treatment fairly.

Q: Will I still get my usual burn care and antibiotics?

Yes, regardless of which group you're in, you will continue to receive all your normal and necessary medical care for your burn, including standard antibiotics.

Q: Can I leave the study if I change my mind?

Absolutely. You are free to withdraw from the study at any time, and this will not affect the quality of your medical care or treatment in any way.

This study is investigating a new way to treat infected small burn wounds using ultrasound technology. It combines tiny bubbles (called microbubbles) with antibiotics, hoping to deliver the medicine better to the infection site. The main goal is to find out if this treatment is safe and practical for patients with infected partial-thickness burns during their hospital stay. They also want to see if there are early signs that it helps patients recover better. If this initial study is successful, it could lead to larger trials and potentially a new, improved method for treating burn infections in the future. Participants will receive either the microbubble treatment or a look-alike inactive treatment, along with their usual burn care, and researchers will monitor for side effects and healing.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Buckinghamshire Healthcare NHS Trust

Enrolment target

Start

31 Mar 2026

Estimated completion

01 Oct 2027

Medical condition: Infected partial-thickness burn wounds (superficial to deep partial-thickness confluent wounds affecting <4% TBSA). Medical condition in lay language: Infections in small burn wounds — specifically partial-thickness burns that have become infected and require treatment during hospital admission. Therapeutic areas: Diseases [C] - Bacterial Infections and Mycoses [C01]

What is this study about?

This research study is looking for better ways to treat small, infected burn wounds. When a burn gets infected, it can take longer to heal and cause more problems. This study is testing a new approach that uses a special kind of ultrasound with tiny bubbles, called microbubbles, along with antibiotics.

Imagine these microbubbles as very tiny vehicles that, when activated by ultrasound, might help deliver antibiotics more effectively to where the infection is in the burn. The idea is to make the antibiotics work better at fighting off the germs. This initial study is important because it will help researchers understand if this new method is safe for patients and if it's practical to use in a hospital setting. They'll also be looking for early signs that it helps patients recover from their infections.

If this small study shows promising results, it means doctors could consider doing a larger study. Ultimately, this research aims to improve how we treat burn infections, potentially leading to faster healing and better outcomes for people with these types of injuries.

Key takeaways

This study explores a new way to treat infected burns using ultrasound and special microbubbles.
It aims to see if this treatment is safe and practical for use in hospitals.
The study involves applying gel, using an ultrasound device, and receiving standard burn care.
You might receive the active treatment or a placebo, chosen randomly.
Potential benefits include helping future burn patients, with low risks similar to standard care.
You can stop participating at any time without affecting your medical treatment.

Who may be eligible?

This study is looking for adults aged 18 or over who are currently staying at the regional burn unit at Buckinghamshire Healthcare NHS Trust. If you have an infected burn that affects only part of your skin – not a full-thickness burn – and covers a small area (less than 4% of your body), you might be able to take part. The infection must be clear to see, and you need to be able to understand the study and agree to join.

There are several reasons why you might not be able to join. For example, if your burn is very large (more than 4% of your body), or if it’s a full-thickness burn, or if you need surgery to graft skin onto the wound. You also can't join if you’re already in another study for burn treatment or antibiotics, or if you have certain allergies to the medicines or gels used in this study.

You also won't be able to participate if you have metal implants near the burn area, other skin conditions there, are pregnant or breastfeeding, have a specific type of superbug infection (MRSA), or if you have certain other medical conditions or are taking specific medications that could interfere with the study treatments.

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 currently an inpatient at Buckinghamshire Healthcare NHS Trust's burn unit?
Do you have a small, infected burn that is not full-thickness?
Are you not in another clinical trial for burn treatment or antibiotics?
Do you have no known allergies to gentamicin, the microbubble contrast, or the gel?
Are you not pregnant or breastfeeding, and do you not have metal implants near your burn?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of two groups: one will receive the new microbubble and antibiotic treatment, and the other will get a treatment that looks the same but contains no active medicine (a placebo). Both groups will still receive all their usual burn care, including regular antibiotics.

The special treatment will involve applying a gel with microbubbles and, for some, an antibiotic called gentamicin, to your burn. Then, a medical device will be used gently over the area for about 30 seconds to 2 minutes. This is done alongside your normal wound care appointments.

During the study, which will happen while you're in the hospital, nurses and doctors will check your burn regularly to see how it's healing and if the infection is improving. They will also look for any side effects and take some wound swabs and routine blood tests, similar to what you'd have during normal care. You might also be asked to answer a few short questions. The whole process, including the treatment and brief questions, will take about 30-45 minutes per session. The study is expected to run from March 2026 to January 2028.

Potential risks and benefits

Because this is an early-stage study, the full benefits aren't known yet. However, by taking part, you could be helping researchers find a new and better way to treat burn infections in the future. The risks of participating are generally thought to be low and similar to the risks you'd experience with normal hospital treatment for an infected burn. You might feel a little warmth, stinging, or tenderness where the gel and ultrasound are applied, but trained staff will ensure you're as comfortable as possible. There's a very small chance of an allergic reaction to the medicines or gels, but you'll be checked for allergies beforehand. Researchers will also closely monitor for any signs of the infection spreading, though this risk is considered extremely low. You will have some wound swabs and blood tests, which might cause mild discomfort. Everything will happen during your hospital stay, so no extra travel is needed. It’s important to remember that you can stop taking part in the study at any time without it affecting your medical care.

Locations (1)

Stoke Mandeville Hospital
Approximate
Aylesbury, England

Common questions

What is a 'partial-thickness' burn?

A partial-thickness burn affects the top layers of your skin, often causing blisters, redness, and pain, but it hasn't damaged all layers like a 'full-thickness' burn would.

What are microbubbles?

Microbubbles are tiny gas bubbles contained in a solution. In this study, they're used with ultrasound to help deliver antibiotics more directly to the infected burn area.

What is a placebo?

A placebo is a treatment that looks exactly like the real treatment but doesn't contain any active medicine. It helps researchers compare the effects of the new treatment fairly.

Will I still get my usual burn care and antibiotics?

Yes, regardless of which group you're in, you will continue to receive all your normal and necessary medical care for your burn, including standard antibiotics.

Can I leave the study if I change my mind?

Absolutely. You are free to withdraw from the study at any time, and this will not affect the quality of your medical care or treatment in any way.

How to find out more

Fadi Issa

fadi.issa@nhs.net +44 (0)1296 418140 Official trial record

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