Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures
NCT05090657
Phase
Phase 2
Recruitment status
Completed
Participants
Lead sponsor
Ondine Biomedical Inc.
Start date
2022-02-04
Number of sites
- Summary
- This is a Phase 2 single-center, open-label, single-arm, study of a microbiological endpoint using antimicrobial photodynamic therapy (aPDT) for nasal disinfection in all patients (universal) presenting for surgery at an acute care hospital for a wide range of surgical procedures.
- Acronym
- BENEFIT-PDT
- Short title
- Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures
- Official title
- Bacterial Eradication of the Nasal Epithelium From Infectious Toxins With PDT (BENEFIT-PDT)
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2022-08-06
- First posted
- 2021-10-25
- Registry last updated
- 2022-08-22
- Primary completion date
- 2022-08-06
- Start date
- 2022-02-04
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Ondine Biomedical Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05090657
- ClinicalTrials.gov ID
- NCT05090657
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Prevention
- Masking
- No masking
- Masking description
- As an infection prevention study the intervention of nasal photodisinfection will be applied to all willing participants within the time frame. Pre and post intervention nasal cultures will be performed. Clinicians will not be aware of these results during the patients hospital course.
Sources for study design
Microbiological efficacy
Timeframe: Within 1 hour of start of surgery
All pre-surgical subjects will be screened by plate culture for Staphylococcus aureus nasal carriage. All subjects will receive the nasal decolonization treatment and then be screened again for Staphylococcus aureus carriage.
Side effects of nasal photodisinfection
Timeframe: 30 days
Subjects will be evaluated for any treatment related side effects including rhinorrhea, mucosal irritation, laryngeal irritation, sneezing or any reported adverse event.
Incidence of surgical site infections
Timeframe: 30 days
Patients will be followed up for any reported post-operative infections
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Provision of signed and dated informed consent form within 30 days of surgery.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female ≥ 18 years of age.
- Patient being admitted for a surgical procedure.
- Ability to tolerate a 4-minute non-painful nasal light illumination.
- Male or female <18 years of age.
- Inability to tolerate insertion of the nasal light illuminator due to nares size, shape, or anatomical variants.
- Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.
- Nasal obstructions precluding placement of light illuminator.
Sources for eligibility
- Memorial University Medical CenterSavannah, United States
Sources for sites