Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections

Официальное название

Leveraging Photodynamic Therapy to Inhibit Microorganisms - Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections in Nasal Surgery Patients: A Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Комбинированный продукт 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).
• Другое 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.
• Диагностический тест 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).
• Диагностический тест 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).
• Другое 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.
• Другое 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

Первичные конечные точки

• Antibiotic usage in number and percentages [Срок оценки: 30 days]

Вторичные конечные точки (3)

• Incidence of surgical site infection [Срок оценки: 30 days]
• Lund-Kennedy Score Assessment [Срок оценки: 30 days]
• Bacterial Nasal Culture Rates [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

-• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Великобритания · 1 центр

• Guy's Hospital — London

Публикации

• 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. PMID 24615873
• 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, o PMID 37852641
• 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. PMID 36160757
• 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. PMID 33914049
• 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. PMID 25171975
• 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. PMID 19905948

Идентификаторы

NCT: NCT06731881 · IRAS345142

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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