Surgical Site Infection Clinical Trial
Official title:
The Effect of Red Light Photobiomodulation and Topical Disinfectants on the Nasal Microbiome
Verified date | February 2023 |
Source | Ondine Biomedical Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | February 8, 2023 |
Est. primary completion date | February 8, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Ondine Research Laboratories | Bothell | Washington |
Lead Sponsor | Collaborator |
---|---|
Ondine Biomedical Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of PBM with Topical Disinfectants (Quantitative) | 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. | The change in bacterial bioburden during the week of each of the four weeks respective intervention. | |
Primary | Effect of PBM with Topical Disinfectants (Semi-Quantitative) | 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. | The change in bacterial bioburden during the week of each of the four weeks respective intervention. | |
Secondary | Effect of PBM with Topical Disinfectants (NGS) | 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. | The change in bacterial bioburden during the week of each of the four weeks respective intervention. |
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