Status:

RECRUITING

Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections

Lead Sponsor:

Guy's and St Thomas' NHS Foundation Trust

Conditions:

Surgery

Nasal Disease

Eligibility:

All Genders

16+ years

Phase:

NA

Brief 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 Steri...

Detailed Description

Preoperative nasal decolonisation has been shown to achieve significant reductions in surgical site infections at sites remote from the nasal cavity. It would therefore seem to have great potential in...

Eligibility 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)

Key Trial Info

Start Date :

June 4 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 31 2025

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06731881

Start Date

June 4 2025

End Date

October 31 2025

Last Update

June 15 2025

Active Locations (1)

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1

Guy's Hospital

London, United Kingdom, SE1 9RT