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

NCT05090657 | Completed Phase 2 FDA Drug FDA Device

• 1 other identifier: BENEFIT-PDT 01
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infections; Nosocomial Infection; Healthcare Associated Infections

Keywords

Staphylococcus aureus; Photodynamic therapy; Photodisinfection; Methylene blue; Nasal decolonization; Surgical infections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of surgical site infections

  30 days

Study Arms (1)

Open label presurgical nasal decolonization

OTHER

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

Interventions

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.

Also known as: photodisinfection (PD), photodynamic therapy (PDT), photoactivated chemotherapy (PACT),

Open label presurgical nasal decolonization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ondine Biomedical Inc.: lead

Study Sites (1)

Memorial University Medical Center

Savannah, Georgia, 31404, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection; Cross Infection; Staphylococcal Infections

Interventions

Methylene Blue; chlorhexidine gluconate; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iatrogenic Disease; Disease Attributes; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Stephen A. Thacker, MD

  Memorial University Medical Center, Savannah, GA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: October 25, 2021
• Study Start: February 4, 2022
• Primary Completion: August 6, 2022
• Study Completion: August 6, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)