Surgical Site InfectionsPhase 2BENEFIT-PDTNCT05090657
Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures
A Phase 2 study testing methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation in people with Surgical Site Infections and Nosocomial Infection, run by Ondine Biomedical Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infections, Nosocomial Infection, Healthcare Associated Infections
- What is being tested?
- methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2022to 6 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial University Medical Center
Savannah, Georgia, 31404
About this study
Official title: Bacterial Eradication of the Nasal Epithelium From Infectious Toxins With PDT (BENEFIT-PDT)
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.
Read the 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.
- Being tested
- methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation
- Keywords
- Staphylococcus aureus, Photodynamic therapy, Photodisinfection, Methylene blue, Nasal decolonization, Surgical infections
- Medical subject headings
- Surgical Wound Infection, Cross Infection, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activationCombination product
Also called photodisinfection (PD), photodynamic therapy (PDT), photoactivated chemotherapy (PACT),
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (1)
Incidence of surgical site infections
Patients will be followed up for any reported post-operative infections
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start4 Feb 2022
- Primary completion6 Aug 2022
- Study completion6 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondine Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen A. Thacker, MD, Principal investigator, Memorial University Medical Center, Savannah, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090657
- Sponsor's protocol ID
- BENEFIT-PDT 01
- Acronym
- BENEFIT-PDT
- Status last verified
- Aug 2022
- First submitted
- 10 Oct 2021
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Eradication of the Nasal Epithelium From Infectious Toxins With PDT (BENEFIT-PDT)
- ClinicalTrials.gov ID
- NCT05090657
- Acronym / sponsor ID
- BENEFIT-PDT / BENEFIT-PDT 01
- Keywords
- Staphylococcus aureus, Photodynamic therapy, Photodisinfection, Methylene blue, Nasal decolonization, Surgical infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Ondine Biomedical Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 6 Aug 2022 (actual)
- Study completion
- 6 Aug 2022 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open label presurgical nasal decolonization | Other | Combination Product: methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activationAlso: photodisinfection (PD), photodynamic therapy (PDT), photoactivated chemotherapy (PACT),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. | Combination product | Open label presurgical nasal decolonization |
Primary outcome
Microbiological efficacy
Time frame: 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
Time frame: 30 days
Subjects will be evaluated for any treatment related side effects including rhinorrhea, mucosal irritation, laryngeal irritation, sneezing or any reported adverse event.
1 secondary outcome
Incidence of surgical site infections
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen A. Thacker, MD principal investigator
Memorial University Medical Center, Savannah, GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation in people with Surgical Site Infections and Nosocomial Infection, run by Ondine Biomedical Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological efficacy (time frame: Within 1 hour of start of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.