Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections

Phase
Recruitment status
Participants
Lead sponsor
Ondine Biomedical Inc.
Start date
Number of sites

Summary
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.
Acronym
Short title
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
Official title
A Group-Randomized, Standard-of-Care-Controlled, Crossover Trial Evaluating Nasal Antimicrobial Photodisinfection for the Prevention of Surgical Site Infections

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Ondine Biomedical Inc.
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Crossover
Purpose
Prevention
Masking
No masking
Sources for study design

  1. Number of Participants with a Surgical Site Infection (SSI) within 30 days post surgery

    Timeframe: Through 30 days post surgery

  2. Percentage of Participants with Treatment-Related Adverse Events within 30 days after surgery.

    Timeframe: Through 30 days post surgery

  1. Mean hospital length of stay after surgery

    Timeframe: From day of surgery (from 1 day up to 30 days)

  2. Number of hospital readmissions within 30 days of surgery

    Timeframe: From day of surgery through 30 days post surgery

  3. Number of Participants with Staph aureus nasal colonization following aPDT (substudy)

    Timeframe: Immediately following aPDT treatment

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  1. Surgical patients, willing to sign the informed consent form and participate in the study.

  2. ≥ 18 years of age

  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 but not limited to the following types:

    1. Cardiac
    2. Vascular
    3. Orthopedic, including spine and 'clean' trauma
    4. Neurosurgery
    5. Breast surgeries
  4. Are able to follow instructions, comply with protocol requirements, and participate in all required study visits.

  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. Surgical indication of infection.

  3. History of surgery within 90 days prior to enrollment.

  4. Anticipated surgery other than the index surgical procedure prior to patient's completion of the study.

  5. Use of other nasal decolonization procedures on the day of surgery prior to the index procedure (mupirocin, povidone iodine, alcohol, etc.).

  6. 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.

  7. Enrollment in concomitant investigational research study in the past 30 days.

    Exclusion Criteria Specific to Treatment Group Patients Only:

  8. Inability to tolerate insertion of the nasal light illuminator due to nasal obstructions or nares size, shape, or anatomical variants.

  9. Known allergic reactions to components of the nasal disinfection treatment including methylene blue or chlorhexidine gluconate.

Sources for eligibility

  • Swedish Medical CenterEnglewood, United States
  • HCA Brandon FloridaBrandon, United States
  • HCA Florida Largo HospitalLargo, United States
  • HCA Florida NorthSide HospitalSt. Petersburg, United States
  • HCA Florida Trinity HospitalTrinity, United States
  • Centennial Medical CenterNashville, United States
  • Medical City Frisco HospitalFrisco, United States
  • HCA Houston Healthcare KingwoodKingwood, United States
  • Medical City PlanoPlano, United States
  • Methodist Metropolitan HospitalSan Antonio, United States
  • Methodist Main Hospital and LandmarkSan Antonio, United States
  • Methodist Stone OakSan Antonio, United States
  • HCA Houston Healthcare Clear Lake HospitalWebster, United States
  • Johnston Willis HospitalRichmond, United States
Sources for sites

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)