RecruitingNot Applicable

Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections

United Kingdom80 participantsStarted 2025-06-04

Plain-language summary

This is a randomised, unblinded interventional device proof of concept pilot trial in which patients undergoing nasal surgery will be selected for either photodisinfection therapy (PDT) with the Steriwave™ ND System, or control with nares swabbed with 'photosensitizer formulation' preoperatively. This trial will primarily assess the safety and efficacy of nasal photodisinfection treatment in decreasing post-operative events in patients undergoing nasal surgery. After signing informed consent, and before surgery, participants will receive a baseline culture of the anterior nares to determine nasal bacterial colonization and will have a flexible nasendoscopy to determine their Lund-Kennedy (LK) endoscopic score. Subjects will then be randomised to nasal PDT (which includes two applications of 'photosensitizer formulation' \[0.01% methylene blue with 0.25% chlorhexidine solution\], two minutes apart), along with light therapy, or control with nares swabbed twice with 'photosensitizer formulation' with two minutes in between (no light therapy). Following treatment, participants will be re-cultured (2 weeks after the surgery ± 7 days) and reviewed for antibiotic use and surgical site infection (SSI) using LK endoscopic scoring. At 30 days, all participants will be followed up by telephone to review if they received antibiotics for presumed postoperative infection. Standard post-operative care will be provided according to the type of surgery performed. Any required interventions post-operatively will be documented.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

• Patients undergoing open septorhinoplasty, anterior or septal biopsies, or post cautery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing photodynamic light therapy to prevent surgical site infections instead of relying on antibiotics — is this something worth considering for the type of surgery I'm having, and what would it mean for how my infection prevention is managed?
2Since this trial is listed as Phase NA, which can sometimes mean it's a device or procedure study rather than a drug trial, can you explain what stage of evidence this approach is at and how confident you are in its safety profile?
3The trial measures antibiotic usage as its main outcome — does that mean there's a chance I might receive fewer or no antibiotics than I normally would, and how would you handle it if I developed an infection during the study?
4Given that this involves applying light therapy inside or around the nose before or after surgery, how would this procedure fit into my existing surgical plan, and would it add extra steps or appointments to my care?
5Would standard antibiotic prophylaxis — the usual infection-prevention approach for my surgery — be a safer or better-established option for me right now compared to participating in this trial?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Antibiotic usage in number and percentages

Timeframe: 30 days

Trial details

NCT IDNCT06731881

SponsorGuy's and St Thomas' NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Claire Hopkins

+442071887188 Claire.Hopkins@gstt.nhs.uk

View on ClinicalTrials.gov More Surgery trials

Plain-language summary