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Open label presurgical nasal decolonization for Surgical Site Infection (BENEFIT-PDT Trial)
Phase 2
Waitlist Available
Led By Stephen A. Thacker, MD
Research Sponsored by Ondine Biomedical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
BENEFIT-PDT 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.
Eligible Conditions
- Surgical Site Infection
- Hospital Acquired Infections
- Healthcare-Associated Infections
BENEFIT-PDT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBENEFIT-PDT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Microbiological efficacy
Side effects of nasal photodisinfection
Secondary outcome measures
Incidence of surgical site infections
BENEFIT-PDT Trial Design
1Treatment groups
Experimental Treatment
Group I: Open label presurgical nasal decolonizationExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
methylene blue 0.01%/chlorhexidine gluconate 0.25% + light activation
2022
Completed Phase 2
~330
Find a Location
Who is running the clinical trial?
Ondine Biomedical Inc.Lead Sponsor
4 Previous Clinical Trials
207 Total Patients Enrolled
Stephen A. Thacker, MDPrincipal InvestigatorMemorial University Medical Center, Savannah, GA
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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