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

NCT05090657 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 322

Last updated 2022-08-22

No results posted yet for this study

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.

Conditions

  • Surgical Site Infections
  • Nosocomial Infection
  • Healthcare Associated Infections

Interventions

COMBINATION_PRODUCT

methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation

After topical application photosensitive solution bilateral nasal light diffusers will be inserted into each nostril and two 2-minute non-thermal light applications of 670 nm light will be used to activate the photosensitizer to achieve an oxidative burst to destroy pathogens.

Sponsors & Collaborators

  • Ondine Biomedical Inc.

    lead INDUSTRY

Principal Investigators

  • Stephen A. Thacker, MD · Memorial University Medical Center, Savannah, GA

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-04
Primary Completion
2022-08-06
Completion
2022-08-06
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05090657 on ClinicalTrials.gov