Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures (BENEFIT-PDT)

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

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.

Study Overview

• Status: Completed
• Conditions: Nosocomial Infection; Surgical Site Infections; Healthcare Associated Infections
• Intervention / Treatment: Combination product: methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Savannah, Georgia, United States, 31404
      • Memorial University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Open label presurgical nasal decolonization; All patients presenting for surgery will be offered nasal decolonization with the combination product. After informed consent a nasal culture will be obtained followed by a 4-minute nasal decolonization treatment and a post-treatment culture. The intervention consists of swabbing the nose with a methylene blue/chlorhexidine gluconate solution followed by non-thermal nasal illumination with red light. There will only be a single treatment.

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.; Other Names: photodisinfection (PD), photodynamic therapy (PDT), photoactivated chemotherapy (PACT),

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological efficacy	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.	Within 1 hour of start of surgery
Side effects of nasal photodisinfection	Subjects will be evaluated for any treatment related side effects including rhinorrhea, mucosal irritation, laryngeal irritation, sneezing or any reported adverse event.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of surgical site infections	Patients will be followed up for any reported post-operative infections	30 days

Collaborators and Investigators

• Sponsor: Ondine Biomedical Inc.
• Investigators: Principal Investigator: Stephen A. Thacker, MD, Memorial University Medical Center, Savannah, GA

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 4, 2022
• Primary Completion (ACTUAL): August 6, 2022
• Study Completion (ACTUAL): August 6, 2022

Study Registration Dates

• First Submitted: October 10, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (ACTUAL): October 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Staphylococcus aureus; Methylene blue; Photodynamic therapy; Nasal decolonization; Photodisinfection; Surgical infections
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Iatrogenic Disease; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Cross Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Disinfectants; Chlorhexidine; Methylene Blue; Chlorhexidine gluconate
• Other Study ID Numbers: BENEFIT-PDT 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes