Photodynamic therapy to prevent infections after nasal surgery
Leveraging Photodynamic Therapy to Inhibit Microorganisms - Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections in Nasal Surgery Patients: A Pilot Study
This study will test whether a preoperative nasal photodisinfection procedure lowers post‑operative infections and antibiotic use in people having elective nasal or sinus surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (London) |
| Trial ID | NCT06731881 on ClinicalTrials.gov |
What this trial studies
This is a randomized, unblinded proof‑of‑concept pilot comparing nasal photodisinfection using the Steriwave™ ND System versus control swabbing with the photosensitizer formulation alone. Participants provide baseline anterior nares cultures and receive flexible nasendoscopy for Lund‑Kennedy scoring before randomization. The intervention group receives two applications of a photosensitizer solution (0.01% methylene blue with 0.25% chlorhexidine) two minutes apart plus light therapy, while controls are swabbed with the photosensitizer without light. Primary focus is on safety and whether the PDT approach reduces post‑operative events, antibiotic use for presumed surgical site infection, and nasal colonization with pathogens such as S. aureus.
Who should consider this trial
Good fit: People aged 16 and older scheduled for elective endoscopic sinus surgery or septoplasty (with or without turbinoplasty) who can give informed consent and follow study procedures are eligible.
Not a fit: Patients who are immunocompromised, on recent immunosuppressive therapy, or undergoing open septorhinoplasty or certain nasal procedures are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the treatment could reduce post‑operative infections and lower the need for antibiotics after nasal surgery.
How similar studies have performed: Nasal decolonisation has reduced surgical site infections in other surgical settings, but photodisinfection specifically for sinonasal surgery is an early, small area of research without large confirmatory trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: -• 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)
Where this trial is running
London
- Guy's Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Claire Hopkins — Guy's and St Thomas' NHS Foundation Trust
- Study coordinator: Claire Hopkins
- Email: Claire.Hopkins@gstt.nhs.uk
- Phone: +442071887188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.