RECRUITING

Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

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Conditions

Surgical Site InfectionsSurgical Wound InfectionInfectionsAnti-Infective AgentsSurgical site infectionnasal decolonizationphotodisinfectionnasal photodisinfectionStaphylococcus aureusPhotodynamic therapyMethylene BluechlorhexidineDisinfection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 3 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major elective, urgent, or emergent surgeries in a hospital setting. The main outcomes are to: 1. compare the efficacy, and 2. estimate the safety of applying nasal (aPDT) before surgery in reducing the incidence of SSIs within the initial 30 days after surgery compared to standard of care (SOC). Participants in the intervention group will receive aPDT prior to surgery on the day of surgery. Participants in the control group will receive standard of care surgical site prevention measures prior to surgery.

Official Title

A Group-Randomized, Standard-of-Care-Controlled, Crossover Trial Evaluating Nasal Antimicrobial Photodisinfection for the Prevention of Surgical Site Infections

Quick Facts

Study Start:2024-12-27
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06702878

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Surgical patients, willing to sign the informed consent form and participate in the study.
  2. 2. ≥ 18 years of age
  3. 3. Presenting to an acute care hospital for major elective, urgent, or emergency surgery, defined as an open procedure involving a significant skin incision, including the following types:
  4. 1. Cardiac
  5. 2. Vascular
  6. 3. Orthopedic, including spine and 'clean' trauma
  7. 4. Neurosurgery
  8. 5. Radical breast surgeries (radical mastectomy with or without reconstruction)
  9. 4. Are able to follow instructions, comply with protocol requirements, and participate in all required study visits.
  1. 1. Pregnancy (current) or currently lactating. If patient is unsure of pregnancy status, a negative urine or serum pregnancy test (sensitive to 25 IU hCG) should be obtained within 14 days prior to surgery.
  2. 2. Surgical indication of infection.
  3. 3. History of surgery within 30 days prior to enrollment.
  4. 4. Anticipated surgery other than the index surgical procedure prior to patient's completion of the study.
  5. 5. Patient has any medical, social or psychiatric condition(s) or current substance abuse condition that, in the opinion of the investigator, would preclude the patient's ability to provide informed consent, or to comply with the study requirements.
  6. 6. Enrollment in concomitant investigational research study in the past 30 days.
  7. 7. Inability to tolerate insertion of the nasal light illuminator due to nasal obstructions or nares size, shape, or anatomical variants.
  8. 8. Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.
  9. 9. Use of other nasal decolonization procedures prior to surgery (mupirocin, povidone iodine, alcohol other).

Contacts and Locations

Study Contact

Simon Sinclair, MD, PhD
CONTACT
1-425-489-1100
ssinclair@ondinebio.com

Principal Investigator

Simon Sinclair, MD, PhD
STUDY_DIRECTOR
Ondine Biomedical

Study Locations (Sites)

Centennial Medical Center
Nashville, Tennessee, 37203
United States
Medical City Frisco Hospital
Frisco, Texas, 75034
United States
Medical City Plano
Plano, Texas, 75075
United States
Methodist Main Hospital
San Antonio, Texas, 78229
United States
Methodist Stone Oak
San Antonio, Texas, 78258
United States
Johnston Willis Hospital
Richmond, Virginia, 23235
United States

Collaborators and Investigators

Sponsor: Ondine Biomedical Inc.

  • Simon Sinclair, MD, PhD, STUDY_DIRECTOR, Ondine Biomedical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-27
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-12-27
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Surgical site infection
  • nasal decolonization
  • photodisinfection
  • nasal photodisinfection
  • Staphylococcus aureus
  • Photodynamic therapy
  • Methylene Blue
  • chlorhexidine
  • Disinfection

Additional Relevant MeSH Terms

  • Surgical Site Infections
  • Surgical Wound Infection
  • Infections
  • Anti-Infective Agents