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Tests treatment safety and results for Surgery
Official title Assessing the Efficacy of Photodynamic Therapy for Preventing Surgical Site Infections
ClinicalTrials.gov ID: NCT06731881
What this study is testing
What is Photosensitizer formulation only?
Photosensitizer formulation only is an investigational medicine, being studied as a potential treatment for surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- 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
You likely can't join if
- - 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...
- 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 eligibility criteria
- 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
- - 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- London, London, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.