Photodynamic therapy to prevent infections after nasal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Guy's Hospital
  London, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.