Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorGuy's and St Thomas' NHS Foundation Trust
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 16 years
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nasal PDT
DeviceTwo 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
Combination productNares 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
Other interventionAll 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
Diagnostic testNasal 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 testSinonasal 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 interventionOn 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
Other interventionOn 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
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: PhotodisinfectionActive comparator 6 interventions
Group B: ControlActive comparator 6 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
30 daysSecondary outcomes
1
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.
Time frame
30 days2
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.
Time frame
30 days3
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.
Time frame
30 daysOther outcomes
1
Safety of PDT
The incidence of adverse events or complications (e.g., nasal irritation, bleeding, discomfort) associated with the nasal photodisinfection procedure, as reported by patients and assessed by clinical examination during the study period.
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov