Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections
Leveraging Photodynamic Therapy to Inhibit Microorganisms - Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections in Nasal Surgery Patients: A Pilot Study
Guy's and St Thomas' NHS Foundation Trust
80 participants
Jun 4, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- Patients ≥ 16 years
- Patients scheduled to undergo elective:
- Endoscopic Sinus Surgery (ESS) with or without adjunctive Septoplasty and/or Turbinoplasty
- Septoplasty with or without adjunctive Turbinoplasty
- Closed Septoplasty with or without adjunctive Turbinoplasty
- Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history and physical examination
- Willing and able to provide written informed consent prior to participation in the clinical investigation
- Willing and able to comply with all study related procedures
Exclusion Criteria14
- • Patients undergoing open septorhinoplasty, anterior or septal biopsies, or post cautery
- Congenital or acquired immunodeficiency, bone marrow disease, diabetes, autoimmune conditions requiring immunosuppressive treatment, any immunosuppressive medication at the time of consent or within the last 4 weeks before randomisation
- Primary or secondary ciliary dyskinesia, cystic fibrosis
- Patients who have received antibiotics within a week before randomisation
- Patients who receive prophylactic antibiotics or antibiotics prior to discharge
- Systemic steroid treatment less than 4 weeks before randomisation
- History of frequent nose bleeds, or a condition that increases the risk of excessive bleeding
- Undergoing active cancer treatment at time of consent/ or planning to start cancer treatment within trial period or completed cancer treatment within the last 4 weeks
- Any disease, condition (medical or surgical), or drug or alcohol abuse, which, in the opinion of the investigator, might compromise the study results, or would place the patient at increased risk of infection
- Previously treated with radiation on the face, head, or neck regions
- Female patients who are pregnant or breastfeeding at the time of consent
- Received a study drug in a clinical trial for an investigational drug within the previous 30 days from consent, or 5 half-lives, whichever is longer
- Used antimicrobial wash or wipes within 7 days of randomisation or during the study period
- Patients with allergies / hypersensitivity to methylene blue, polymethyl methacrylate (PMMA), or to chlorhexidine gluconate (CHG)
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Interventions
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.
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).
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.
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).
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).
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.
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06731881