Evaluation of the Impact of Germicidal Light (Indigo-Clean) on Intraoperative S. Aureus Exposure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

824 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Operating room S. aureus exposure has been directly linked to postoperative infections and is therefore an important target for infection prevention. Visible light (non-ultraviolet spectrum) at 405nm has been shown to be germicidal. We hypothesize that use of this light in operating rooms will reduce S. aureus transmission occurring within and between patients and reduce surgical site infections (SSIs). Visible light is safe for routine, continual exposure, and is less harmful than sunlight. We plan to install ambient, germicidal lighting in 4 operating rooms. This ambient light is not directly applied to patients (does not involve the surgical procedure lights). Patients will undergo surgery according to usual practice. We will conduct a case-control study where operating rooms with surgeries with the lights are matched to operating rooms with surgeries without lights.

In Aim 1, 4 OR-pairs will be observed each day over an anticipated 103 working days for the primary outcome of S. aureus transmission events over a total minimum study period of 5.2 months (103 working days).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Germicidal Light

NCT03886337

Bacterial Transmission S.Aureus Transmission Operating Room Exposure to S. Aureus +1 more

WITHDRAWN NA

Proof-of-concept Study on Disinfection and Healing Acceleration Capabilities of 222nm Wave Length Narrow Band Ultraviolet Lighting Device

NCT03526068

Ultraviolet Rays

COMPLETED NA

The Effect of Plasma-air-filtration on the Incidence of Surgical Site Infections in Orthopaedic Surgery

NCT02695368

Orthopaedic Surgery (30 Minutes or Longer)

COMPLETED NA

The Role of Circadian Clock Proteins in Innate and Adaptive Immunity

NCT03482245

Pneumonia Necrotizing Soft Tissue Infection Intraabdominal Infections +1 more

RECRUITING NA

Ultra Violet-C Light Evaluation as an Adjunct to Removing Multi-Drug Resistant Organisms (UVCLEAR-MDRO)

NCT02605499

Healthcare Associated Infection Multidrug Resistant Organisms

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pathogen Transmission

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

405nm light room

In this room, surgeries will be performed under ambient light including the wavelength 405nm

Group Type EXPERIMENTAL

405nm light

Intervention Type DEVICE

In this room, surgeries will be performed under ambient light including the wavelength 405nm

Control room

In this room, surgeries will be performed under ambient light from regular phosphorescent light does not include 405nm frequencies

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

405nm light

In this room, surgeries will be performed under ambient light including the wavelength 405nm

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Operating Rooms with and without the bactericidal lights where adult patients undergoing orthopedic, cardiothoracic, gynecology/oncology, and neurological surgery.

Exclusion Criteria

* Operating Rooms with and without the bactericidal lights where pediatric, incarcerated, and/or pregnant patients undergoing surgery outside of the classifications above.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes