💬In plain words
What the trial is, and whether it could suit you
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 min
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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)
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