Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures

Completed · Phase 2

Conditions studied: Surgical Site Infections, Nosocomial Infection, Healthcare Associated Infections

In brief

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.

Key facts

Study ID

NCT05090657

Run by

Ondine Biomedical Inc.

People needed

322

Starts

2022-02-04

Expected to finish

2022-08-06

Last updated by the study team

2022-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form within 30 days of surgery.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female ≥ 18 years of age.
• Patient being admitted for a surgical procedure.
• Ability to tolerate a 4-minute non-painful nasal light illumination.

You may not qualify if…

• Male or female <18 years of age.
• Inability to tolerate insertion of the nasal light illuminator due to nares size, shape, or anatomical variants.
• Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.
• Nasal obstructions precluding placement of light illuminator.

Where it is running

• Memorial University Medical Center — Savannah, Georgia, United States

Full record on ClinicalTrials.gov

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