Red Light Photobiomodulation and Topical Disinfectants
- Conditions
- Surgical Site InfectionHealthcare Associated InfectionNosocomial Infection
- Interventions
- Device: Methylene Blue OnlyDevice: Chlorhexidine Gluconate OnlyDevice: Methylene Blue + Chlorhexidine GluconateDevice: Light Only
- Registration Number
- NCT05797818
- Lead Sponsor
- Ondine Biomedical Inc.
- Brief Summary
The goal of this clinical trial is to evaluate the potential effects of photobiomodulation when used with topical disinfectants in the anterior nares of healthy adults.
Over a three week period, participants will have their anterior nares swabbed with methylene blue, chlorhexidine gluconate, or a combination of the two followed by 4 minutes of non-thermal red light treatment. The fourth week of consist of only red light treatment. Culture samples of the subjects nasal microbiome will be taken prior to treatment, immediately after treatment, 4-, 8-, 24-, and 48 hours after treatment.
- Detailed Description
This is an exploratory, single-center, open-label, single-arm study with microbiological endpoint using photobiomodulation (PBM) and topical disinfectants to determine the effect on the nasal microbiota.
The photobiomodulation system distributes about 700mW of light to each nostril using a 2-channel diode laser with non-thermal, red light. The topical disinfectants are methylene blue (0.01%) and chlorhexidine gluconate (0.25%). Following a pretreatment nasal culture, these two disinfectants will be administered into the patient's anterior nares followed by a two-minute light cycle. This process is repeated once more resulting in two treatments cycles (4-minutes total). Following this, nasal cultures are taken immediately and at 4-, 8-, 24-, and 48- hours. Broad spectrum and Staphylococcus spp. culturing of nasal swabs will be conducted. Swabs will also be submitted for Next Generation Sequencing to characterize the effect of light and disinfectants on the nasal microbiome.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- Subjects must be 18 years of age or older
- Pregnant Women
- Those Under 18 years of age
- Prisoners
- Mentally Disabled Persons
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Methylene Blue Methylene Blue Only All subjects will have an initial baseline culture done of their nasal microbiome followed by an administration of 0.01% methylene blue solution. Next, subjects will undergo two minute of non-thermal red light exposure. A second round of solution administration and light exposure will be repeated resulting in 4 minutes of red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment. Chlorhexidine gluconate Chlorhexidine Gluconate Only All subjects will have an initial baseline culture done of their nasal microbiome followed by an administration of 0.25% chlorhexidine solution. Next, subjects will undergo two minute of non-thermal red light exposure. A second round of solution administration and light exposure will be repeated resulting in 4 minutes of red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment. Methylene blue and Chlorhexidine gluconate Methylene Blue + Chlorhexidine Gluconate All subjects will have an initial baseline culture done of their nasal microbiome followed by an administration of 0.01% methylene blue and 0.25% chlorhexidine gluconate solution. Next, subjects will undergo two minute of non-thermal red light exposure. A second round of solution administration and light exposure will be repeated resulting in 4 minutes of red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment. Light Only Light Only All subjects will have an initial baseline culture done of their nasal microbiome followed by 4 minutes of non-thermal red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment.
- Primary Outcome Measures
Name Time Method Effect of PBM with Topical Disinfectants (Quantitative) The change in bacterial bioburden during the week of each of the four weeks respective intervention. The Quantitative outcome measure is the change from baseline in nasal bacterial bioburden (measured in CFU/mL) by the effects of red light photobiomodulation on nasal bacteria when used with and without topical disinfectants. Each subject's baseline nasal bacterial level is determined prior to the weekly intervention. There are no subject reported outcome measures.
Effect of PBM with Topical Disinfectants (Semi-Quantitative) The change in bacterial bioburden during the week of each of the four weeks respective intervention. The Semi-quantitative outcome measure is the change in bacterial growth between different time points measured by the number of quadrants with bacterial growth on a culture plate. Photographs of each culture plate will allow visual comparisons between time points. Each subject's baseline nasal bacterial level is determined prior to the weekly intervention.
- Secondary Outcome Measures
Name Time Method Effect of PBM with Topical Disinfectants (NGS) The change in bacterial bioburden during the week of each of the four weeks respective intervention. Nasal culture responses over several days will be evaluated using Next Generation Sequencing (NGS) to determine how long it takes for the nasal microbiome to return to its previous non-treated level. NGS allows for determining what percentage of the total microbiome a certain species of bacteria is.
Trial Locations
- Locations (1)
Ondine Research Laboratories
🇺🇸Bothell, Washington, United States