Leveraging Photodynamic Therapy to Inhibit Microorganisms - Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections in Nasal Surgery Patients A Pilot Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of photodisinfection therapy PDT using the Steriwave14 ND System compared to a control swabbing with a photosensitizer formulation in patients undergoing nasal surgery. This pilot trial aims to reduce the use of antibiotics for presumed surgical site infections SSI by eliminating harmful bacteria in the nasal passages before surgery. The study also investigates how well nasal decolonisation removes Staphylococcus aureus and other microbes from the nose, which could help prevent infections after surgery. Participants will be randomly assigned to either receive nasal PDT, which involves two applications of a photosensitizer solution containing methylene blue and chlorhexidine followed by light therapy, or to a control group where their noses are swabbed twice with the photosensitizer solution without light exposure. The PDT treatment is administered in two two-minute cycles before surgery using a CE-marked device and disposable applicators. The control group undergoes the swabbing procedure only. All patients will receive standard post-operative care and wound follow-up according to their surgery type. Before treatment, nasal swabs and flexible nasendoscopy will be done to measure bacterial colonization and inflammation. Participants will have repeat swabs and endoscopy about two weeks after surgery, and a telephone follow-up at 30 days to check antibiotic use and signs of infection. Researchers will assess antibiotic usage, incidence of SSI, nasal bacterial cultures, and inflammation scores. The total follow-up period is 30 days, during which any post-operative interventions will be documented to evaluate the therapys safety and effectiveness.

Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections