Modification of the Lund-Kennedy endoscopic scoring system improves its reliability and correlation with patient-reported outcome measures.
Alkis J Psaltis, Gang Li, Reza Vaezeafshar...
https://pubmed.ncbi.nlm.nih.gov/24615873Actively Recruiting
Phase Not Applicable
Age: 16Years +
All Genders
ID06731881
Leveraging Photodynamic Therapy to Inhibit Microorganisms - Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections in Nasal Surgery Patients: A Pilot Study
Led by Guy's and St Thomas' NHS Foundation Trust · Updated on 2025-06-15
80
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
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 therapy's safety and effectiveness.
CONDITIONS
Brief Title
Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections
Who Can Participate
Age: 16Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients 16 years or older
- Scheduled for elective Endoscopic Sinus Surgery with or without Septoplasty and/or Turbinoplasty
- Scheduled for elective Septoplasty with or without Turbinoplasty
- Scheduled for closed Septoplasty with or without Turbinoplasty
- Suitable for study participation based on medical history and physical exam
- Able and willing to provide written informed consent
- Able and willing to comply with all study procedures
You will not qualify if you...
- Undergoing open septorhinoplasty, anterior or septal biopsies, or post cautery procedures
- Have congenital or acquired immunodeficiency, bone marrow disease, diabetes, autoimmune conditions requiring immunosuppressive treatment, or recent immunosuppressive medication
- Diagnosed with primary or secondary ciliary dyskinesia or cystic fibrosis
- Received antibiotics within 7 days before randomisation
- Receiving prophylactic antibiotics or antibiotics before discharge
- Treated with systemic steroids less than 4 weeks before randomisation
- History of frequent nosebleeds or conditions increasing bleeding risk
- Undergoing active cancer treatment, planning to start cancer treatment during the trial, or completed cancer treatment within 4 weeks
- Any medical or surgical condition or substance abuse that may increase infection risk or affect study results
- Previously treated with radiation on face, head, or neck
- Female patients who are pregnant or breastfeeding
- Participated in another investigational drug trial within 30 days or 5 half-lives
- Used antimicrobial wash or wipes within 7 days before randomisation or during the study
- Allergic or sensitive to methylene blue, polymethyl methacrylate, or chlorhexidine gluconate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 1 day
Participants receive nasal photodynamic therapy or control swabbing with photosensitizer formulation on the day of surgery prior to the procedure.
1 visit (in-person on the day of surgery)
Post-operative Follow-up
Duration - 2 weeks (+/- 7 days)
Participants are monitored with nasal swab cultures and flexible nasendoscopy to assess bacterial burden and mucosal inflammation, followed by standard post-operative wound care and review.
1 in-person visit around Week 2
Follow-up
Duration - 30 days after surgery
Participants receive a telephone follow-up call to review adverse events, medications, symptoms, nasal washout, and antibiotic use after surgery.
1 telephone call on Day 30
Trial Site Locations
Total: 1 location
1
Guy's Hospital
London, United Kingdom, SE1 9RT
Actively Recruiting
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Research Team
C
Claire Hopkins
N
Nora Haloob
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial.
Sean Carrie, James O'Hara, Tony Fouweather...
https://pubmed.ncbi.nlm.nih.gov/37852641Pre-surgical Nasal Decolonization of Staphylococcus aureus: A Health Technology Assessment.
Ontario Health (Quality)
https://pubmed.ncbi.nlm.nih.gov/36160757Nasal Microbiota and Infectious Complications After Elective Surgical Procedures.
Chiaowen Joyce Hsiao, Joseph N Paulson, Sarabdeep Singh...
https://pubmed.ncbi.nlm.nih.gov/33914049Nasal photodisinfection and chlorhexidine wipes decrease surgical site infections: a historical control study and propensity analysis.
E Bryce, T Wong, L Forrester...
https://pubmed.ncbi.nlm.nih.gov/25171975Antimicrobial photodynamic therapy may promote periodontal healing through multiple mechanisms.
Pam Braham, Caroline Herron, Cale Street...
https://pubmed.ncbi.nlm.nih.gov/19905948Treatment of periodontal disease by photodisinfection compared to scaling and root planing.
Roger Andersen, Nicolas Loebel, David Hammond...
https://pubmed.ncbi.nlm.nih.gov/17508621There is no clinical evidence of consequences after methylene blue chromoendoscopy.
M Dinis-Ribeiro, L Moreira-Dias
https://pubmed.ncbi.nlm.nih.gov/18513562ASGE Technology Committee systematic review and meta-analysis assessing the ASGE Preservation and Incorporation of Valuable Endoscopic Innovations thresholds for adopting real-time imaging-assisted endoscopic targeted biopsy during endoscopic surveillance of Barrett's esophagus.
ASGE Technology Committee, Nirav Thosani, Barham K Abu Dayyeh...
https://pubmed.ncbi.nlm.nih.gov/26874597Removal of red light minimizes methylene blue-stimulated DNA damage in oesophageal cells: implications for chromoendoscopy.
R G Sturmey, C P Wild, L J Hardie
https://pubmed.ncbi.nlm.nih.gov/19218330