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Impact of Germicidal Light

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University of Iowa

Status

Withdrawn

Conditions

Operating Room Exposure to S. Aureus
Bacterial Transmission
S.Aureus Transmission
90-day Postoperative Surgical Site Infections, Superficial and Deep

Treatments

Device: Germicidal lighting

Study type

Interventional

Funder types

Other

Identifiers

NCT03886337
201901773

Details and patient eligibility

About

Visible light at 405nm has been shown to be germicidal. The hypothesis is that use of this light (Indigo-Clean Lights) in operating rooms will reduce S. aureus transmission occurring within and between patients and reduce surgical site infections (SSIs). Investigators will evaluate a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without germicidal lights.

Full description

Operating room S. aureus exposure has been directly linked to postoperative infections and is therefore an important target for infection prevention. Visible light at 405nm has been shown to be germicidal. Investigators plan to install ambient, germicidal lighting (Indigo-Clean Lights) that uses this wavelength in 4 operating rooms. Patients will undergo surgery according to usual practice. Investigators will conduct a case-control study where patients undergoing surgery with the lights are matched with patients undergoing surgery without the germicidal lights. Patients will be matched by procedure then case duration then American Society of Anesthesiologists (ASA) physical status health classification. These patients will undergo infection surveillance. Infection surveillance will involve use of National Healthcare Safety Network (NHSN) checklists applied to patients who are positive for one or more of the initial screening criteria (elevated white blood cell count, fever (>38.4 degrees Celsius), office note documentation of infection, positive culture (sputum, blood, urine, wound, other body fluid), or anti-infective order within the 90 postoperative day period.

Sex

All

Ages

18 to 120 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Adult, at least 18 years old
  • Adult patients undergoing orthopedic, cardiothoracic, gyn/onc, and neuro surgery and general anesthesia according to usual care with peripheral and/or central venous access.

Exclusion criteria

  • Pediatric (<18 years old),
  • Incarcerated, and/or
  • Pregnant patients
  • Undergoing surgery and/or without peripheral or central venous access.
  • Undergoing surgery outside of the classifications above

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Control
No Intervention group
Description:
The control arm will be surgical care according to usual practice with usual ambient lighting
Treatment Arm
Experimental group
Description:
The treatment arm will include surgical care according to usual practice with germicidal ambient lighting
Treatment:
Device: Germicidal lighting

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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