80
Participants
Start Date
June 4, 2025
Primary Completion Date
August 31, 2025
Study Completion Date
October 31, 2025
Nasal PDT
Two two-minute cycles will be provided by a member of the research team in the pre-operative area on the day of surgery. A saturated swab containing 0.01% methylene blue and 0.25% chlorhexidine gluconate will be applied to nares, which is then activated by light.
Photosensitizer formulation only
Nares will be swabbed with Photosensitizer formulation (0.01% methylene blue with 0.25% chlorhexidine solution). Nasal swab cultures will be obtained before control swabbing and converted to colony-forming units to measure bacterial burden at baseline, and after treatment (2 weeks +/- 7 days). Sinonasal mucosal inflammation using the Flexible Nasendoscopy Endoscopic LK Score will also be obtained before treatment at 2 weeks (+/-7 days).
Standard follow-up
All patients will receive standard post-operative wound follow up. This might include being advised to contact the GP or the hospital if there are any wound problems and, or, being invited to an out-patient clinic appointment.
Nasal culture
Nasal swab cultures will be obtained before Nasal PDT or control swabbing and converted to colony-forming units to measure bacterial burden at baseline, and after treatment (2 weeks +/- 7 days).
Flexible nasendoscopy
Sinonasal mucosal inflammation using the Flexible Nasendoscopy Endoscopic Lund-Kennedy (LK) Score will also be obtained before Nasal PDT or control swabbing and at 2 weeks (+/-7 days).
In-person review
On Week 2 (±7 days), the participant will undergo an in-person review conducted in the ENT Outpatient department, 2nd floor Southwark wing, Guy's Hospital by the CI, PI or Co-investigator. During this appointment, concomitant medications and use of post-operative antibiotics will be reviewed.
Telephone Follow-up
"On day 30, the research nurse will telephone participants from the ENT research office.~* Review of adverse events/adverse device effects~* Review of concomitant medications~* Signs and symptoms post-surgery~* Nasal washout~* Record any use of post-operative antibiotics, both local and systemic"
RECRUITING
Guy's Hospital, London
Guy's and St Thomas' NHS Foundation Trust
OTHER