Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections

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.

Conditions

• Surgery
• Nasal Disease
• Light; Therapy, Complications

Interventions

DEVICE

Nasal PDT

Two two-minute cycles will be provided by a member of the research team in the pre-operative area on the day of surgery. A saturated swab containing 0.01% methylene blue and 0.25% chlorhexidine gluconate will be applied to nares, which is then activated by light.

COMBINATION_PRODUCT

Photosensitizer formulation only

Nares will be swabbed with Photosensitizer formulation (0.01% methylene blue with 0.25% chlorhexidine solution). Nasal swab cultures will be obtained before control swabbing and converted to colony-forming units to measure bacterial burden at baseline, and after treatment (2 weeks +/- 7 days). Sinonasal mucosal inflammation using the Flexible Nasendoscopy Endoscopic LK Score will also be obtained before treatment at 2 weeks (+/-7 days).

OTHER

Standard follow-up

All patients will receive standard post-operative wound follow up. This might include being advised to contact the GP or the hospital if there are any wound problems and, or, being invited to an out-patient clinic appointment.

DIAGNOSTIC_TEST

Nasal culture

Nasal swab cultures will be obtained before Nasal PDT or control swabbing and converted to colony-forming units to measure bacterial burden at baseline, and after treatment (2 weeks +/- 7 days).

DIAGNOSTIC_TEST

Flexible nasendoscopy

Sinonasal mucosal inflammation using the Flexible Nasendoscopy Endoscopic Lund-Kennedy (LK) Score will also be obtained before Nasal PDT or control swabbing and at 2 weeks (+/-7 days).

OTHER

In-person review

On Week 2 (±7 days), the participant will undergo an in-person review conducted in the ENT Outpatient department, 2nd floor Southwark wing, Guy's Hospital by the CI, PI or Co-investigator. During this appointment, concomitant medications and use of post-operative antibiotics will be reviewed.

OTHER

Telephone Follow-up

On day 30, the research nurse will telephone participants from the ENT research office. * Review of adverse events/adverse device effects * Review of concomitant medications * Signs and symptoms post-surgery * Nasal washout * Record any use of post-operative antibiotics, both local and systemic

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Claire Hopkins · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-04

Primary Completion

2025-08-31

Completion

2025-10-31

Countries

• United Kingdom

Study Locations