Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections
NCT ID: NCT06731881
Last Updated: 2025-06-15
Study Results
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Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-06-04
2025-10-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Photodisinfection
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.
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.
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.
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).
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).
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.
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
Control
The control group will have nares swabbed with 'photosensitizer formulation' (0.01% methylene blue with 0.25% chlorhexidine solution) prior to surgery.
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).
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.
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).
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).
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.
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
Interventions
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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.
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).
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.
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).
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).
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
16 Years
ALL
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Claire Hopkins
Role: PRINCIPAL_INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust
Locations
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Guy's Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Carrie 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.
Rochon 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.
Hsiao 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.
Bryce 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.
Braham 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.
Andersen 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.
Andersen 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.
ASGE 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.
Millson 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.
Olliver 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.
Davies J, Burke D, Olliver JR, Hardie LJ, Wild CP, Routledge MN. Methylene blue but not indigo carmine causes DNA damage to colonocytes in vitro and in vivo at concentrations used in clinical chromoendoscopy. Gut. 2007 Jan;56(1):155-6. doi: 10.1136/gut.2006.107300. No abstract available.
Canto MI, Setrakian S, Petras RE, Blades E, Chak A, Sivak MV Jr. Methylene blue selectively stains intestinal metaplasia in Barrett's esophagus. Gastrointest Endosc. 1996 Jul;44(1):1-7. doi: 10.1016/s0016-5107(96)70221-3.
Kohli Y, Pfeiffer CJ, Kutty KP, Barrowman JA, Heughan C, Kepkay DL. Endoscopic diagnosis of intestinal metaplasia in Canada and Japan. J Clin Gastroenterol. 1981;3 Suppl 1:29-33. doi: 10.1097/00004836-198100031-00006.
Suzuki S, Suzuki H, Endo M, Takemoto T, Kondo T. Endoscopic diagnosis of early cancer and intestinal metaplasia of the stomach by dyeing. Int Surg. 1973 Sep;58(9):639-42. No abstract available.
Shah-Khan MG, Lovely J, Degnim AC. Safety of methylene blue dye for lymphatic mapping in patients taking selective serotonin reuptake inhibitors. Am J Surg. 2012 Nov;204(5):798-9. doi: 10.1016/j.amjsurg.2012.02.004. Epub 2012 May 9.
FDA Drug Safety Communication dated 26 July 2011 - accessed on 31 January 2019 at - http://www.fda.gov/Drugs/DrugSafety/ucm263190.htm
Dewachter P, Mouton-Faivre C, Trechot P, Lleu JC, Mertes PM. Severe anaphylactic shock with methylene blue instillation. Anesth Analg. 2005 Jul;101(1):149-50, table of contents. doi: 10.1213/01.ANE.0000153497.60047.80.
Bezu C, Coutant C, Salengro A, Darai E, Rouzier R, Uzan S. Anaphylactic response to blue dye during sentinel lymph node biopsy. Surg Oncol. 2011 Mar;20(1):e55-9. doi: 10.1016/j.suronc.2010.10.002. Epub 2010 Nov 11.
Masannat YA, Hanby A, Horgan K, Hardie LJ. DNA damaging effects of the dyes used in sentinel node biopsy: possible implications for clinical practice. J Surg Res. 2009 Jun 15;154(2):234-8. doi: 10.1016/j.jss.2008.07.039. Epub 2008 Sep 4.
Wainwright M, Crossley KB. Methylene Blue--a therapeutic dye for all seasons? J Chemother. 2002 Oct;14(5):431-43. doi: 10.1179/joc.2002.14.5.431.
Silva ZS Jr, Bussadori SK, Fernandes KP, Huang YY, Hamblin MR. Animal models for photodynamic therapy (PDT). Biosci Rep. 2015 Sep 28;35(6):e00265. doi: 10.1042/BSR20150188.
Dai T, Tegos GP, Zhiyentayev T, Mylonakis E, Hamblin MR. Photodynamic therapy for methicillin-resistant Staphylococcus aureus infection in a mouse skin abrasion model. Lasers Surg Med. 2010 Jan;42(1):38-44. doi: 10.1002/lsm.20887.
Zolfaghari PS, Packer S, Singer M, Nair SP, Bennett J, Street C, Wilson M. In vivo killing of Staphylococcus aureus using a light-activated antimicrobial agent. BMC Microbiol. 2009 Feb 4;9:27. doi: 10.1186/1471-2180-9-27.
Fang CH, Fastenberg JH, Fried MP, Jerschow E, Akbar NA, Abuzeid WM. Antibiotic use patterns in endoscopic sinus surgery: a survey of the American Rhinologic Society membership. Int Forum Allergy Rhinol. 2018 Apr;8(4):522-529. doi: 10.1002/alr.22085. Epub 2018 Jan 15.
Abuzeid W, Shah S, Hawn V, Fang C, Akbar N. Postoperative infection rates and associated factors following endoscopic sinus surgery. Int Forum Allergy Rhinol 2019; 9(10);1227. First Published online: August 20, 2019
Virkkula P, Makitie AA, Vento SI. Surgical outcome and complications of nasal septal perforation repair with temporal fascia and periosteal grafts. Clin Med Insights Ear Nose Throat. 2015 Apr 29;8:7-11. doi: 10.4137/CMENT.S23230. eCollection 2015.
Dabrowska-Bien J, Skarzynski PH, Gwizdalska I, Lazecka K, Skarzynski H. Complications in septoplasty based on a large group of 5639 patients. Eur Arch Otorhinolaryngol. 2018 Jul;275(7):1789-1794. doi: 10.1007/s00405-018-4990-8. Epub 2018 May 16.
von Eiff C, Becker K, Machka K, Stammer H, Peters G. Nasal carriage as a source of Staphylococcus aureus bacteremia. Study Group. N Engl J Med. 2001 Jan 4;344(1):11-6. doi: 10.1056/NEJM200101043440102.
Kuehnert MJ, Kruszon-Moran D, Hill HA, McQuillan G, McAllister SK, Fosheim G, McDougal LK, Chaitram J, Jensen B, Fridkin SK, Killgore G, Tenover FC. Prevalence of Staphylococcus aureus nasal colonization in the United States, 2001-2002. J Infect Dis. 2006 Jan 15;193(2):172-9. doi: 10.1086/499632. Epub 2005 Dec 15.
Khorvash F, Abdi F, Kashani HH, Naeini FF, Narimani T. Staphylococcus aureus in Acne Pathogenesis: A Case-Control Study. N Am J Med Sci. 2012 Nov;4(11):573-6. doi: 10.4103/1947-2714.103317.
Zanger P, Nurjadi D, Vath B, Kremsner PG. Persistent nasal carriage of Staphylococcus aureus is associated with deficient induction of human beta-defensin 3 after sterile wounding of healthy skin in vivo. Infect Immun. 2011 Jul;79(7):2658-62. doi: 10.1128/IAI.00101-11. Epub 2011 Apr 4.
Wertheim HF, Melles DC, Vos MC, van Leeuwen W, van Belkum A, Verbrugh HA, Nouwen JL. The role of nasal carriage in Staphylococcus aureus infections. Lancet Infect Dis. 2005 Dec;5(12):751-62. doi: 10.1016/S1473-3099(05)70295-4.
National Healthcare Safety Network, Centers for Disease Control and Prevention. Surgical site infection (SSI) event. http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf. Published January 2017.
Bachert C, Pawankar R, Zhang L, Bunnag C, Fokkens WJ, Hamilos DL, Jirapongsananuruk O, Kern R, Meltzer EO, Mullol J, Naclerio R, Pilan R, Rhee CS, Suzaki H, Voegels R, Blaiss M. ICON: chronic rhinosinusitis. World Allergy Organ J. 2014 Oct 27;7(1):25. doi: 10.1186/1939-4551-7-25. eCollection 2014.
Annys E, Jorissen M. Short term effects of antibiotics (Zinnat) after endoscopic sinus surgery. Acta Otorhinolaryngol Belg. 2000;54(1):23-8.
Fernandes SV. Postoperative care in functional endoscopic sinus surgery? Laryngoscope. 1999 Jun;109(6):945-8. doi: 10.1097/00005537-199906000-00020.
Jorissen M, Bachert C. Effect of corticosteroids on wound healing after endoscopic sinus surgery. Rhinology. 2009 Sep;47(3):280-6. doi: 10.4193/Rhin08.227.
Other Identifiers
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IRAS345142
Identifier Type: -
Identifier Source: org_study_id
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