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

Phase 2

Completed

• Conditions: Surgical Site Infections; Healthcare Associated Infections; Nosocomial Infection
• Interventions: Combination Product: methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation

• Registration Number: NCT05090657
• Lead Sponsor: Ondine Biomedical Inc.

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.

Study Timeline

• Study First Submitted: 2021-10-10
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-10-25
• Study Start: 2022-02-04
• Status Verified: 2022-08
• Primary Completion: 2022-08-06
• Study Completion: 2022-08-06
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open label presurgical nasal decolonization	methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Incidence of surgical site infections	30 days	Patients will be followed up for any reported post-operative infections

Trial Locations

Locations (1)

Memorial University Medical Center; 🇺🇸 Savannah, Georgia, United States