Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections

NARecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 4, 2025

Primary Completion Date

August 31, 2025

Study Completion Date

October 31, 2025

Conditions
SurgeryNasal DiseaseLight; Therapy, Complications
Interventions
DEVICE

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.

COMBINATION_PRODUCT

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).

OTHER

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.

DIAGNOSTIC_TEST

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).

DIAGNOSTIC_TEST

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).

OTHER

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.

OTHER

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"

Trial Locations (1)

SE1 9RT

RECRUITING

Guy's Hospital, London

All Listed Sponsors
lead

Guy's and St Thomas' NHS Foundation Trust

OTHER

NCT06731881 - Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections | Biotech Hunter | Biotech Hunter