Red Light Photobiomodulation and Topical Disinfectants

Surgical Site Infection Clinical Trial

Official title:

The Effect of Red Light Photobiomodulation and Topical Disinfectants on the Nasal Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05797818
• Other study ID #: 31686-2022
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 10, 2023
• Est. completion date: February 8, 2023

Study information

• Verified date: February 2023
• Source: Ondine Biomedical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Healthcare Associated Infection
• Infections
• Nosocomial Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Device:
• Methylene 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
• Chlorhexidine 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
• Methylene 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
• Light 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

Locations

Country	Name	City	State
United States	Ondine Research Laboratories	Bothell	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ondine Biomedical Inc.

Country where clinical trial is conducted

United States, 

Outcome

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.