RecruitingNAINTERVENTIONAL

Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections

This study is investigating a new way to help prevent infections after nasal surgery. It's called 'photodynamic therapy' (PDT), which uses a special cleaning solution and light to disinfect the inside of your nose. We want to see if this treatment, given before your surgery, can safely and effectively reduce the chances of developing a surgical site infection and needing antibiotics afterwards. Participants will be randomly assigned to either receive this light-based treatment or just the cleaning solution without the light. We will then check for infections and antibiotic use in the weeks following surgery. This is a small initial study to see if a larger study would be worthwhile, providing important information to improve patient care.

At a glance

Status

Recruiting

Phase

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

Start

04 Jun 2025

Estimated completion

31 Oct 2025

Surgery Nasal Disease Light; Therapy, Complications

What is this study about?

This study is designed to explore a new treatment called 'photodynamic therapy' (PDT) to help prevent infections after nasal surgery. Many operations carry a risk of infection, and surgeons and patients alike want to minimise this. Sometimes, bacteria naturally present in your nose can cause problems after surgery, leading to an infection at the surgical site. This can mean a longer recovery and the need for antibiotics.

The idea behind PDT is to use a special liquid, which makes bacteria sensitive to light, along with a specific type of light to kill these germs in your nose before surgery. This treatment is called 'photodisinfection'. We want to find out if using this method can safely reduce the number of bacteria in your nose before an operation, and therefore lower the chance of you developing an infection afterwards. If it works well, it could mean fewer patients need antibiotics after surgery, which is good for individual health and also helps in the bigger effort to reduce antibiotic resistance.

This is a pilot study, which means it's a smaller, initial investigation. We're looking at whether this treatment is safe and if there's enough evidence to suggest it's effective. If the results are promising, it would pave the way for a larger study that could definitively prove its benefits. We hope this research will help us find better ways to keep you healthy and recovering smoothly after nasal surgery.

Key takeaways

This study tests a new light-based treatment (PDT) to prevent nasal surgery infections.
It aims to reduce the need for antibiotics after surgery.
Participants will either receive PDT or a cleaning solution only.
Involves nose swabs, a nasal scope, and follow-up for 30 days.
It's a pilot study to see if a larger investigation is warranted.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 16 years old and planning to have certain types of elective (pre-booked) nasal surgery, such as surgery on your sinuses, nasal septum, or turbinates. The study doctors will also check your medical history to make sure it's safe for you to participate and that you're well enough to complete all the study steps.

There are some reasons why you might not be able to join. These include if you're having certain other types of nasal surgery (like open nose reshaping or biopsies), have certain medical conditions that affect your immune system (like severe diabetes or autoimmune diseases requiring specific treatments), or have conditions like cystic fibrosis. If you've recently taken antibiotics or certain steroid medications, or if you have a history of frequent nosebleeds, you might also not be eligible.

We also can't include women who are pregnant or breastfeeding, or anyone currently undergoing active cancer treatment or who has recently completed it. If you've had radiation therapy to your head or neck in the past, or if you've been part of another drug trial recently, you wouldn't be able to join this study either. The study team will discuss all these points with you to make sure it's the right fit.

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 16 years old or older?
Are you having specific types of elective nasal surgery (e.g., sinus, septum, turbinate surgery)?
Are you able to attend follow-up appointments and calls?
Are you NOT pregnant or breastfeeding?
Have you NOT taken antibiotics recently (within the last week)?
Do you NOT have conditions severely affecting your immune system or frequent nosebleeds?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here's what you can expect:

* **Signing Up:** After discussing the study with the team and agreeing to participate, you'll sign an informed consent form. * **Initial Checks (Before Surgery):** Before your operation, we'll take a swab from the front of your nose to check for bacteria. You'll also have a flexible tube with a camera (a flexible nasendoscopy) gently inserted into your nose to assess its condition. * **Treatment:** Just before your surgery, you'll be randomly assigned to one of two groups. One group will have the special cleaning liquid applied to their nose twice, two minutes apart, followed by light therapy. The other group will have the same cleaning liquid applied twice, but without the light therapy. * **After Surgery:** You'll receive your usual post-operative care. Around two weeks after your surgery, you'll have another nose swab and a follow-up appointment (in-person) where we'll check for any signs of infection or if you've needed antibiotics. * **Final Check:** Approximately 30 days after your surgery, we'll give you a quick phone call to ask if you received any antibiotics for potential infections after your operation. Any unplanned medical attention you receive after surgery will also be recorded. The total duration of your active participation will be about 30 days.

Potential risks and benefits

Participating in this study might offer the potential benefit of reducing your risk of a surgical site infection after nasal surgery, which could mean a smoother recovery and less need for antibiotics. However, there's no guarantee that you will personally benefit. Potential risks are generally low, as the treatment involves a solution and light therapy that are usually well-tolerated. You might experience some mild discomfort from the nose swabs or the light treatment, but these are generally temporary. All procedures carry some small risks, which the study team will explain fully. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Guy's Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is photodynamic therapy (PDT)?

It's a treatment that uses a special liquid applied to your nose, followed by light. The liquid makes bacteria sensitive to the light, which then kills them, helping to disinfect the area.

Why is this study being done?

We want to see if this light-based treatment before nasal surgery can effectively reduce the risk of infections afterwards and therefore decrease the need for antibiotics.

Will I definitely get the light treatment?

No, you'll be randomly assigned to either receive the light treatment after getting the special liquid, or just receive the special liquid without the light. This helps us compare the two approaches fairly.

How long will I be involved in the study?

Your active participation will be for about 30 days, starting from before your surgery until the final phone call follow-up.

Are there any side effects?

Generally, the treatment is well-tolerated. You might feel some mild discomfort from the nasal swabs or the light, but these usually pass quickly. The study team will discuss any potential risks with you.

How to find out more

Claire Hopkins

Claire.Hopkins@gstt.nhs.uk +442071887188 Official trial record

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