SurgeryLIGHTNCT06731881
Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections
A study testing Nasal PDT, Photosensitizer formulation only and Standard follow-up in people with Surgery and Nasal Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Surgery, Nasal Disease, Light; Therapy, Complications
- What is being tested?
- Nasal PDT, Photosensitizer formulation only and Standard follow-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -• 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's Hospital
London, London, SE1 9RT
Nora Haloob, +447737075302, nora.haloob@gstt.nhs.uk
Karen Cariaga, +447477896641, Karen.Cariaga1@nhs.net
About this study
Official title: Leveraging Photodynamic Therapy to Inhibit Microorganisms - Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections in Nasal Surgery Patients: A Pilot Study
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.
Read the detailed description
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.
- Conditions
- Surgery, Nasal Disease, Light; Therapy, Complications
- Being tested
- Nasal PDT, Photosensitizer formulation only, Standard follow-up, Nasal culture, Flexible nasendoscopy
- Keywords
- nasal surgery, nasal photodisinfection, decolonisation, surgical site infection
- Medical subject headings
- Nose Diseases, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal PDTDevice
Also called Steriwave (SW4000)
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 onlyCombination 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).
Standard follow-upOther
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 cultureDiagnostic 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 nasendoscopyDiagnostic 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 reviewOther
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-upOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (3)
Incidence of surgical site infection
The proportion of patients developing a postoperative infection within 30 days of surgery, defined by the presence of sinus purulence (Lund-Kennedy score of 2: 'Thick and purulent discharge') on nasal endoscopy and requiring antibiotic treatment.
Measured: 30 days
Lund-Kennedy Score Assessment
The change in Lund-Kenned (LK) scores from baseline during the study period, as measured by flexible nasendoscopy, in patients who received preoperative PDT compared to those in the control group.
Each side is graded on an ordinal scale from 0-2, with higher scores indicating worse disease.
Measured: 30 days
Bacterial Nasal Culture Rates
The percentage of patients with positive bacterial cultures (S. aureus and Group A Streptococcus) from nasal swabs during the study period, comparing the PDT group with the control group.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start4 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Hopkins, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731881
- Sponsor's protocol ID
- IRAS345142
- Acronym
- LIGHT
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The trial will be conducted in accordance with the Data Protection Act 2018. The chief investigator will ensure that participant's anonymity is maintained throughout the study and following completion of the study. Pseudonymised data will be shared with the study Statistician who is an employee of the Trust and member of the study team. It will be extracted from REDCap and sent via encrypted email in a locked Excel document. After the analysis the data will be archived in Iron Mountain. No data will be shared outside of GSTT during the course of the study. Data will not be shared with the device manufacturer.
Publications
Psaltis AJ, Li G, Vaezeafshar R, Cho KS, Hwang PH. Modification of the Lund-Kennedy endoscopic scoring system improves its reliability and correlation with patient-reported outcome measures. Laryngoscope. 2014 Oct;124(10):2216-23. doi: 10.1002/lary.24654. Epub 2014 Apr 2.
PubMed 24615873Carrie S, O'Hara J, Fouweather T, Homer T, Rousseau N, Rooshenas L, Bray A, Stocken DD, Ternent L, Rennie K, Clark E, Waugh N, Steel AJ, Dooley J, Drinnan M, Hamilton D, Lloyd K, Oluboyede Y, Wilson C, Gardiner Q, Kara N, Khwaja S, Leong SC, Maini S, Morrison J, Nix P, Wilson JA, Teare MD. Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial. BMJ. 2023 Oct 18;383:e075445. doi: 10.1136/bmj-2023-075445.
PubMed 37852641Rochon M, Jawarchan A, Ingusan S, Cariaga K and Morais C. 'Project ID007672: Clinical audit of patient-reported antibiotics for wound problems following surgery and review of alternative strategies'. 2023 Feb 25. Unpublished.
Street CN, Pedigo L, Gibbs A, Loebel NG. Antimicrobial photodynamic therapy for the decolonization of methicillin-resistant Staphylococcus aureus from the anterior nares, Proc. SPIE 7380, Photodynamic Therapy: Back to the Future, 73803B (13 July 2009); https://doi.org/10.1117/12.828279
Ontario Health (Quality). Pre-surgical Nasal Decolonization of Staphylococcus aureus: A Health Technology Assessment. Ont Health Technol Assess Ser. 2022 Aug 23;22(4):1-165. eCollection 2022.
PubMed 36160757Hsiao CJ, Paulson JN, Singh S, Mongodin EF, Carroll KC, Fraser CM, Rock P, Faraday N. Nasal Microbiota and Infectious Complications After Elective Surgical Procedures. JAMA Netw Open. 2021 Apr 1;4(4):e218386. doi: 10.1001/jamanetworkopen.2021.8386.
PubMed 33914049Bryce E, Wong T, Forrester L, Masri B, Jeske D, Barr K, Errico S, Roscoe D. Nasal photodisinfection and chlorhexidine wipes decrease surgical site infections: a historical control study and propensity analysis. J Hosp Infect. 2014 Oct;88(2):89-95. doi: 10.1016/j.jhin.2014.06.017. Epub 2014 Aug 1.
PubMed 25171975Braham P, Herron C, Street C, Darveau R. Antimicrobial photodynamic therapy may promote periodontal healing through multiple mechanisms. J Periodontol. 2009 Nov;80(11):1790-8. doi: 10.1902/jop.2009.090214.
PubMed 19905948Andersen R, Loebel N, Hammond D, Wilson M. Treatment of periodontal disease by photodisinfection compared to scaling and root planing. J Clin Dent. 2007;18(2):34-8.
PubMed 17508621Andersen R, Loebel N. Photodynamic Disinfection in the Treatment of Chronic Adult Periodontitis: A Multicentre Clinical Trial. J Dent Health Oral Disord Ther 2017, 8(4): 00289. DOI: 10.15406/jdhodt.2017.08.00289
Dinis-Ribeiro M, Moreira-Dias L. There is no clinical evidence of consequences after methylene blue chromoendoscopy. Gastrointest Endosc. 2008 Jun;67(7):1209. doi: 10.1016/j.gie.2007.12.043. No abstract available.
PubMed 18513562ASGE Technology Committee; Thosani N, Abu Dayyeh BK, Sharma P, Aslanian HR, Enestvedt BK, Komanduri S, Manfredi M, Navaneethan U, Maple JT, Pannala R, Parsi MA, Smith ZL, Sullivan SA, Banerjee S. ASGE 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. Gastrointest Endosc. 2016 Apr;83(4):684-98.e7. doi: 10.1016/j.gie.2016.01.007. Epub 2016 Feb 11.
PubMed 26874597Millson CE, Thurrell W, Buonaccorsi G, et al. The effect of low power laser light at different doses on gastric mucosa sensitised with methylene blue, hematoporphyrin derivative or toluidine blue. Laser Med Sci 1997; 12:145-150.
Sturmey RG, Wild CP, Hardie LJ. Removal of red light minimizes methylene blue-stimulated DNA damage in oesophageal cells: implications for chromoendoscopy. Mutagenesis. 2009 May;24(3):253-8. doi: 10.1093/mutage/gep004. Epub 2009 Feb 13.
PubMed 19218330Olliver JR, Wild CP, Sahay P, Dexter S, Hardie LJ. Chromoendoscopy with methylene blue and associated DNA damage in Barrett's oesophagus. Lancet. 2003 Aug 2;362(9381):373-4. doi: 10.1016/s0140-6736(03)14026-3.
PubMed 12907012
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Photodynamic Therapy to Inhibit Microorganisms - Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections in Nasal Surgery Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT06731881
- Acronym / sponsor ID
- LIGHT / IRAS345142
- Conditions
- Surgery, Nasal Disease, Light; Therapy, Complications
- Keywords
- nasal surgery, nasal photodisinfection, decolonisation, surgical site infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Photodisinfection | Active comparator | Device: Nasal PDT, Other: Standard follow-up, Diagnostic Test: Nasal culture, Diagnostic Test: Flexible nasendoscopy, Other: In-person review, Other: Telephone Follow-upThe 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. |
| Control | Active comparator | Combination Product: Photosensitizer formulation only, Other: Standard follow-up, Diagnostic Test: Nasal culture, Diagnostic Test: Flexible nasendoscopy, Other: In-person review, Other: Telephone Follow-upThe control group will have nares swabbed with 'photosensitizer formulation' (0.01% methylene blue with 0.25% chlorhexidine solution) prior to surgery. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients ≥ 16 years
- Patients scheduled to undergo elective:
- 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
Key exclusion criteria (14 listed)
- -• 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal PDTAlso: Steriwave (SW4000)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. | Device | Photodisinfection |
| Photosensitizer formulation onlyNares 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). | Combination product | Control |
| Standard follow-upAll 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. | Other | Control, Photodisinfection |
| Nasal cultureNasal 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 | Control, Photodisinfection |
| Flexible nasendoscopySinonasal 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). | Diagnostic test | Control, Photodisinfection |
| In-person reviewOn 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 | Control, Photodisinfection |
| Telephone Follow-upOn 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 | Other | Control, Photodisinfection |
Primary outcome
Antibiotic usage in number and percentages
Time frame: 30 days
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.
3 secondary outcomes
Incidence of surgical site infection
Time frame: 30 days
Lund-Kennedy Score Assessment
Time frame: 30 days
Bacterial Nasal Culture Rates
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 24615873Psaltis AJ, Li G, Vaezeafshar R, Cho KS, Hwang PH. Modification of the Lund-Kennedy endoscopic scoring system improves its reliability and correlation with patient-reported outcome measures. Laryngoscope. 2014 Oct;124(10):2216-23. doi: 10.1002/lary.24654. Epub 2014 Apr 2.
- Background: PubMed 37852641Carrie S, O'Hara J, Fouweather T, Homer T, Rousseau N, Rooshenas L, Bray A, Stocken DD, Ternent L, Rennie K, Clark E, Waugh N, Steel AJ, Dooley J, Drinnan M, Hamilton D, Lloyd K, Oluboyede Y, Wilson C, Gardiner Q, Kara N, Khwaja S, Leong SC, Maini S, Morrison J, Nix P, Wilson JA, Teare MD. Clinical effectiveness of septoplasty versus medical management for nasal airways obstruction: multicentre, open label, randomised controlled trial. BMJ. 2023 Oct 18;383:e075445. doi: 10.1136/bmj-2023-075445.
- BackgroundRochon M, Jawarchan A, Ingusan S, Cariaga K and Morais C. 'Project ID007672: Clinical audit of patient-reported antibiotics for wound problems following surgery and review of alternative strategies'. 2023 Feb 25. Unpublished.
- BackgroundStreet CN, Pedigo L, Gibbs A, Loebel NG. Antimicrobial photodynamic therapy for the decolonization of methicillin-resistant Staphylococcus aureus from the anterior nares, Proc. SPIE 7380, Photodynamic Therapy: Back to the Future, 73803B (13 July 2009); https://doi.org/10.1117/12.828279
- Background: PubMed 36160757Ontario Health (Quality). Pre-surgical Nasal Decolonization of Staphylococcus aureus: A Health Technology Assessment. Ont Health Technol Assess Ser. 2022 Aug 23;22(4):1-165. eCollection 2022.
- Background: PubMed 33914049Hsiao CJ, Paulson JN, Singh S, Mongodin EF, Carroll KC, Fraser CM, Rock P, Faraday N. Nasal Microbiota and Infectious Complications After Elective Surgical Procedures. JAMA Netw Open. 2021 Apr 1;4(4):e218386. doi: 10.1001/jamanetworkopen.2021.8386.
- Background: PubMed 25171975Bryce E, Wong T, Forrester L, Masri B, Jeske D, Barr K, Errico S, Roscoe D. Nasal photodisinfection and chlorhexidine wipes decrease surgical site infections: a historical control study and propensity analysis. J Hosp Infect. 2014 Oct;88(2):89-95. doi: 10.1016/j.jhin.2014.06.017. Epub 2014 Aug 1.
- Background: PubMed 19905948Braham P, Herron C, Street C, Darveau R. Antimicrobial photodynamic therapy may promote periodontal healing through multiple mechanisms. J Periodontol. 2009 Nov;80(11):1790-8. doi: 10.1902/jop.2009.090214.
- Background: PubMed 17508621Andersen R, Loebel N, Hammond D, Wilson M. Treatment of periodontal disease by photodisinfection compared to scaling and root planing. J Clin Dent. 2007;18(2):34-8.
- BackgroundAndersen R, Loebel N. Photodynamic Disinfection in the Treatment of Chronic Adult Periodontitis: A Multicentre Clinical Trial. J Dent Health Oral Disord Ther 2017, 8(4): 00289. DOI: 10.15406/jdhodt.2017.08.00289
- Background: PubMed 18513562Dinis-Ribeiro M, Moreira-Dias L. There is no clinical evidence of consequences after methylene blue chromoendoscopy. Gastrointest Endosc. 2008 Jun;67(7):1209. doi: 10.1016/j.gie.2007.12.043. No abstract available.
- Background: PubMed 26874597ASGE Technology Committee; Thosani N, Abu Dayyeh BK, Sharma P, Aslanian HR, Enestvedt BK, Komanduri S, Manfredi M, Navaneethan U, Maple JT, Pannala R, Parsi MA, Smith ZL, Sullivan SA, Banerjee S. ASGE 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. Gastrointest Endosc. 2016 Apr;83(4):684-98.e7. doi: 10.1016/j.gie.2016.01.007. Epub 2016 Feb 11.
- Individual participant dataSharing planned: No. The trial will be conducted in accordance with the Data Protection Act 2018. The chief investigator will ensure that participant's anonymity is maintained throughout the study and following completion of the study. Pseudonymised data will be shared with the study Statistician who is an employee of the Trust and member of the study team. It will be extracted from REDCap and sent via encrypted email in a locked Excel document. After the analysis the data will be archived in Iron Mountain. No data will be shared outside of GSTT during the course of the study. Data will not be shared with the device manufacturer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire Hopkins principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal PDT, Photosensitizer formulation only and Standard follow-up in people with Surgery and Nasal Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire Hopkins (+442071887188 ext. 82215, Claire.Hopkins@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic usage in number and percentages (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06731881, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.