Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called photodynamic therapy (PDT) to see if it helps prevent infections after nasal surgery. In this study, patients who are scheduled for certain types of nasal surgeries, like endoscopic sinus surgery or septoplasty, will be randomly assigned to receive either the PDT treatment, which includes a special light therapy, or a control treatment where only a solution is applied without the light. The main goal is to find out if using this light therapy can lower the chances of getting an infection after the surgery.

To participate in this trial, you need to be at least 16 years old and scheduled for specific elective nasal surgeries. The researchers will first check your nasal bacteria and use a flexible camera to assess your nasal passages. After your surgery, they will follow up with you about two weeks later to see if you developed any infections or needed antibiotics. It’s important to know that certain medical conditions and medications might prevent you from joining the study, but if you’re interested, the study team will help determine if you qualify.

Gender

ALL

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)