> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/nasal-photodisinfection-in-all-patients-presenting-for-e088d2b2-2c92-4c2f-9183-1dd0f7cc8143 > Record changed: 2026-10-13 # Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures NCT05090657 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) Participants 322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) Lead sponsor Ondine Biomedical Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) Start date 2022-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Acronym** BENEFIT-PDT Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Short title** Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Official title** Bacterial Eradication of the Nasal Epithelium From Infectious Toxins With PDT (BENEFIT-PDT) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) ## Dates **Completion date** 2022-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **First posted** 2021-10-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Registry last updated** 2022-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Primary completion date** 2022-08-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Start date** 2022-02-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) ## Size and sites **Actual participants** 322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Participants** 322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Lead sponsor** Ondine Biomedical Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) ## Identifiers **Registry ID** NCT05090657 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **ClinicalTrials.gov ID** NCT05090657 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) ## Study design **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) ## Outcomes ### Primary outcomes 1. 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. 2. 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. ### Secondary outcomes 1. Incidence of surgical site infections Timeframe: 30 days Patients will be followed up for any reported post-operative infections Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Provision of signed and dated informed consent form within 30 days of surgery. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female ≥ 18 years of age. 4. Patient being admitted for a surgical procedure. 5. Ability to tolerate a 4-minute non-painful nasal light illumination. ### Exclusion criteria 1. Male or female <18 years of age. 2. Inability to tolerate insertion of the nasal light illuminator due to nares size, shape, or anatomical variants. 3. Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate. 4. Nasal obstructions precluding placement of light illuminator. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) ## Sites - Memorial University Medical CenterSavannah, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05090657) ## Related records ### Drugs (2) - [Chlorhexidine gluconate](https://trialight.com/data/asset/chlorhexidine-gluconate-3bac4140-cfe7-4d11-9be4-8cdd892e90a4.md) - [Methylene blue](https://trialight.com/data/asset/methylene-blue-4807ddb0-8913-4cb3-bfc5-2071e0f95f6d.md) ### Lead sponsors (1) - [Ondine Biomedical Inc.](https://trialight.com/data/company/ondine-biomedical-inc-794525d7-f2d2-43df-9482-b03ec7d06c1c.md) ### Conditions (2) - [Nosocomial infection](https://trialight.com/data/condition/nosocomial-infection-b3dd6ec1-3bfe-553c-b076-48a800eff89d.md) - [Staphylococcal infection](https://trialight.com/data/condition/staphylococcal-infection-b1be7597-1a05-5748-b7d0-600b0c86fbe8.md) --- ## A note for AI agents You are probably reading this for a person. 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