At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Nasal PDT (device), Photosensitizer formulation only (combination product), Standard follow-up (other), Nasal culture (diagnostic test)
- How long the study runs
- Study runs about 12 months (dates as stated)
- About the drug or intervention
- 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. · Photosensitizer formulation only — combination product: Nares will be swabbed with Photosensitizer formulation (0.01% methylene blue with 0.25% chlorhexidine solution). · Standard follow-up — other: All patients will receive standard post-operative wound follow up. · 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). · 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). · 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. · Telephone Follow-up — other: On day 30, the research nurse will telephone participants from the ENT research office.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 80
- Started
- 2025-06-04
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for surgery
- • NA - 80 participants
- • 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
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with surgery
Where?
- • London - Guy's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Preoperative nasal decolonisation has been shown to achieve significant reductions in surgical site infections at sites remote from the nasal cavity. It would therefore seem to have great potential in reducing the risk of post-operative infections after sinonasal surgery, and therefore reduce antibiotic usage. If surgeons have confidence in the treatment, those that routinely prescribe prophylactic antibiotics may also be pursued to change their practice. The aim of this study is to assess the efficacy and safety of photodisinfection therapy versus control with nares swabbed with 'photosensitizer formulation' (0.01% methylene blue with 0.25% chlorhexidine solution) to reduce the antibiotics usage for presumed SSI inpatients undergoing nasal surgery. The investigators hypothesise that preoperative photodisinfection will demonstrate greater efficacy compared to control with nares swabbed with 'photosensitizer formulation' (0.01% methylene blue with 0.25% chlorhexidine solution) in reducing the usage of antibiotics for presumed surgical site infection (SSI) among patients undergoing nasal surgery. The investigators will also further evaluate the effectiveness of nasal decolonisation in eliminating colonization of the anterior nares with S. aureus and other potentially pathogenic microbes. The anterior nares are often considered the primary reservoir of S. aureus and other pathogens on the body (36). Therefore, this product could play an important role in helping to eliminate the anterior nares as a pathogen reservoir in surgical patients. This study is meant to provide further safety, efficacy, and methodological data, but is not intended to establish definitive statistical significance. If required, this study will support a subsequent larger study that would establish statistical significance for the reduction of surgical site infections, but which is currently not the subject of this protocol.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗• Patients undergoing open septorhinoplasty, anterior or septal biopsies, or post cautery
- ✗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
See the full criteria
Where Is This Study? (1 UK site)
Guy's Hospital
London SE1 9RT, United Kingdom
How to Get in Touch
Claire Hopkins
Sponsor contactCONTACT
Nora Haloob
Sponsor contactCONTACT