Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections

NCT06731881 | Recruiting DMC

• 1 other identifier: IRAS345142
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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 minutes apart), along with light therapy, or control with nares swabbed twice with 'photosensitizer formulation' with two minutes in between (no light therapy). Following treatment, participants will be re-cultured (2 weeks after the surgery ± 7 days) and reviewed for antibiotic use and surgical site infection (SSI) using LK endoscopic scoring. At 30 days, all participants will be followed up by telephone to review if they received antibiotics for presumed postoperative infection. Standard post-operative care will be provided according to the type of surgery performed. Any required interventions post-operatively will be documented.

Conditions

Surgery; Nasal Disease; Light; Therapy, Complications

Keywords

nasal surgery; nasal photodisinfection; decolonisation; surgical site infection

Outcome Measures

Primary Outcomes (1)

• Antibiotic usage in number and percentages

  The proportion of patients requiring antibiotic therapy for presumed surgical site infections (SSIs) within 30 days after undergoing nasal surgery. Specifically, the intention is to compare those who received preoperative PDT with those in the control group.

  30 days

Secondary Outcomes (3)

• Incidence of surgical site infection

  30 days

• Lund-Kennedy Score Assessment

  30 days

• Bacterial Nasal Culture Rates

  30 days

Other Outcomes (1)

• Safety of PDT

  30 days

Study Arms (2)

Photodisinfection

ACTIVE COMPARATOR

The photodisinfection product consists of a CE-marked light source (SW4000), a disposable single-use nasal light diffuser, and a single-use photosensitiser applicator that can be used in hospital settings.

Device: Nasal PDT; Other: Standard follow-up; Diagnostic Test: Nasal culture; Diagnostic Test: Flexible nasendoscopy; Other: In-person review; Other: Telephone Follow-up

Control

ACTIVE COMPARATOR

The control group will have nares swabbed with 'photosensitizer formulation' (0.01% methylene blue with 0.25% chlorhexidine solution) prior to surgery.

Combination Product: Photosensitizer formulation only; Other: Standard follow-up; Diagnostic Test: Nasal culture; Diagnostic Test: Flexible nasendoscopy; Other: In-person review; Other: Telephone Follow-up

Interventions

Nasal PDT DEVICE

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.

Also known as: Steriwave (SW4000)

Photodisinfection

Photosensitizer formulation only COMBINATION_PRODUCT

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).

Control

Standard follow-up OTHER

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.

Control; Photodisinfection

Nasal culture DIAGNOSTIC_TEST

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).

Control; Photodisinfection

Flexible nasendoscopy DIAGNOSTIC_TEST

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).

Control; Photodisinfection

In-person review OTHER

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.

Control; Photodisinfection

Telephone Follow-up OTHER

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

Control; Photodisinfection

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's Hospital

London, SE1 9RT, United Kingdom

RECRUITING

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MeSH Terms

Conditions

Nose Diseases; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Claire Hopkins

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Hopkins

CONTACT

+442071887188; Claire.Hopkins@gstt.nhs.uk

Nora Haloob

CONTACT

+447737075302; Nora.Haloob@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised, interventional proof of concept pilot trial in which patients undergoing nasal surgery will be selected for either photodisinfection therapy with the Steriwave™ ND System, or control with nares swabbed with 'photosensitizer formulation' (0.01% methylene blue with 0.25% chlorhexidine solution) prior to surgery

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 13, 2024
• Study Start: June 4, 2025
• Primary Completion: August 31, 2025
• Study Completion: October 31, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)