NCT06731881: LIGHT

Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections

Recruiting now NA Last updated 15 June 2025

What this trial tests

NA trial testing Nasal PDT in Surgery in 80 participants. Currently enrolling.

Timeline

4 June 2025

Primary endpoint
31 August 2025

31 October 2025

Quick facts

Lead sponsor	Guy's and St Thomas' NHS Foundation Trust
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	80
Start date	4 June 2025
Primary completion	31 August 2025
Estimated completion	31 October 2025
Sites	1 location across United Kingdom

Drugs / interventions tested

• Nasal PDT
• Photosensitizer formulation only
• Standard follow-up
• Nasal culture
• Flexible nasendoscopy
• In-person review
• Telephone Follow-up

Conditions studied

• Surgery — all drugs for Surgery →
• Nasal Disease — all drugs for Nasal Disease →
• Light; Therapy, Complications — all drugs for Light; Therapy, Complications →

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Who can join

16 and older, any sex, with Surgery or Nasal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Antimicrobial Resistance: The Answers.
   Millar BC, Cates MJ, Torrisi MS, Round AJ, et al · · 2026 · PMID 41727556 · DOI 10.3389/bjbs.2026.15559