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

Nosocomial Infection Clinical Trial

— BENEFIT-PDT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05090657
• Other study ID #: BENEFIT-PDT 01
• Status: Completed
• Phase: Phase 2
• Start date: February 4, 2022
• Est. completion date: August 6, 2022

Study information

• Verified date: August 2022
• Source: Ondine Biomedical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: August 6, 2022
• Est. primary completion date: August 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Healthcare Associated Infections
• Infections
• Nosocomial Infection
• Surgical Site Infections
• Surgical Wound Infection

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial University Medical Center	Savannah	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Ondine Biomedical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Incidence of surgical site infections	Patients will be followed up for any reported post-operative infections	30 days