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

NCT ID: NCT05090657

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 322 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-04
• Study Completion Date: 2022-08-06

Brief 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.

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.

Conditions

Surgical Site Infections; Nosocomial Infection; Healthcare Associated Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

photodisinfection (PD), photodynamic therapy (PDT), photoactivated chemotherapy (PACT),

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondine Biomedical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen A. Thacker, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial University Medical Center, Savannah, GA

Locations

Memorial University Medical Center

Savannah, Georgia, United States

Countries

United States

Other Identifiers

BENEFIT-PDT 01

Identifier Type: -

Identifier Source: org_study_id