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

What Was Tested

In this phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner).

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.

It had 1 arm (groups): 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.

The registry classes the interventions as combination product.

More on the Plan

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.

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.

Who Took Part

322 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-02-04 with completion listed for 2022-08-06.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Side effects of nasal photodisinfection (time frame: 30 days).

It also tracked 1 secondary outcome, for example Incidence of surgical site infections.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Methylene blue (non-peptide stack partner) in 322 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.