- Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections — Recruiting • Non-phase study • Respiratory / COPD / Asthma • NCT06731881.
- What is being tested: Photodynamic therapy (PDT) using the Steriwave™ ND System to prevent surgical site infections in patients undergoing nasal surgery, compared with control treatment using photosensitizer formulation alone.
- Patient eligibility overview: Adults undergoing nasal surgery are recruited and randomly assigned to either PDT intervention or control group, with preoperative nasal swabbing in both arms to reduce bacterial colonisation before surgery.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.