Healthcare Associated Infection, Nosocomial Infection, Surgical Site Infection
Conditions
Keywords
Staphylococcal aureus, Methylene blue, Chlorhexidine gluconate, Nasal decolonization, Photobiomodulation, Photodynamic therapy, Nasal microbiome
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.
Interventions
DEVICEMethylene Blue Only
All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: \- Methylene Blue (0.01%) + 4 minutes of light treatment
DEVICEChlorhexidine Gluconate Only
All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: \- Chlorhexidine gluconate (0.25%) + 4 minutes of light treatment
DEVICEMethylene Blue + Chlorhexidine Gluconate
All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: \- Methylene blue (0.01%) + chlorhexidine gluconate (0.25%) + 4 minutes of light treatment
DEVICELight Only
All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: \- 4 minutes of light treatment only
Sponsors
Ondine Biomedical Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
A single open-label healthy group is being evaluated for any changes to the normal nasal microbiome. Each week nasal cultures will be done and the subject exposed to different interventions including red light alone, and several disinfectants. Nasal cultures will be done for 48 hours after the intervention to determine the effect, if any, on the nasal microbiome.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be 18 years of age or older
Exclusion criteria
* Pregnant Women * Those Under 18 years of age * Prisoners * Mentally Disabled Persons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed