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

Sponsor

Ondine Biomedical Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05090657

Collaborator

(none)

500

Enrollment

Location

Arm

3.9

Anticipated Duration (Months)

129

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infections Nosocomial Infection Healthcare Associated Infections	Combination Product: methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The sample size will be one month of all surgical cases and is estimated at 500-600 cases. Both genders and a wide range of ages and medical conditions will be represented from all ethnic/demographic groups and of varying health status.The sample size will be one month of all surgical cases and is estimated at 500-600 cases. Both genders and a wide range of ages and medical conditions will be represented from all ethnic/demographic groups and of varying health status.

Masking:

None (Open Label)

Masking Description:

As an infection prevention study the intervention of nasal photodisinfection will be applied to all willing participants within the time frame. Pre and post intervention nasal cultures will be performed. Clinicians will not be aware of these results during the patients hospital course.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 4, 2022

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Jun 2, 2022

Arms and Interventions

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),

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),

Outcome Measures

Primary Outcome Measures

Microbiological efficacy [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.
Side effects of nasal photodisinfection [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 Outcome Measures

Incidence of surgical site infections [30 days]
Patients will be followed up for any reported post-operative infections

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.