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Completed

NCT Number: NCT05090657

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

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.

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Key information

Conditions

Surgical Site Infections Bacterial Infections Bacterial Infections and Mycoses Cross Infection Disease Attributes Gram-Positive Bacterial Infections Healthcare Associated Infections Iatrogenic Disease Infections Nosocomial Infection Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Staphylococcal Infections Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial University Medical Center

Savannah, Georgia, 31404, United States

About this study

The purpose of the proposed study is to gather data regarding the safety and efficacy of nasal photodisinfection treatment in eliminating colonization of the anterior nares with S. aureus. The anterior nares are often considered the primary reservoir of S. aureus and other pathogens on the body, therefore, this product could play an important role in helping to eliminate this pathogen reservoir in patients. Since photodisinfection is a non-antibiotic approach that does not generate antibiotic resistance, this could be a beneficial approach to achieving nasal disinfection. Additionally, photodisinfection has an extremely broad spectrum of activity and is effective against bacterial, viral, and fungal pathogens including emerging pathogens such as C. auris.

This is a Phase 2 study. Nasal cultures will be performed on all patients admitted for surgery at Memorial Health University Medical Center over a 1-month period. This will determine the prevalence rate of S. aureus and other pathogens in community patients who are being admitted for surgery. The results of this culture will not be known to the research staff until several days later. Clinical trial subjects will universally receive a nasal disinfection treatment followed by a post-treatment culture. This will demonstrate the efficacy of nasal disinfection against Staphylococcus aureus and methicillin-resistant Staphylococcus aureus.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Combination Product

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.

Other names: photodisinfection (PD), photodynamic therapy (PDT), photoactivated chemotherapy (PACT),

Primary outcomes

  1. Microbiological efficacy

    Time frame: 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

    Time frame: 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

    Time frame: 30 days

    Patients will be followed up for any reported post-operative infections

Sponsors and collaborators

Lead sponsor

Ondine Biomedical Inc.

Industry

Registry information

Official study title

Bacterial Eradication of the Nasal Epithelium From Infectious Toxins With PDT (BENEFIT-PDT)

Acronym: BENEFIT-PDT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2021
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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