Reducing Perioperative S. Aureus Transmission

R

Randy Loftus

Status

Terminated

Conditions

Health Care Worker Patient Transmission
Health Care Associated Infection
Staphylococcus Aureus

Treatments

Device: Swab and decolonization using povidone-iodine cleansing

Study type

Interventional

Funder types

Other

Identifiers

NCT03638947
201802843

Details and patient eligibility

About

The purpose of this study is to prevent the spread of S. aureus, a dangerous bacterium, within the operating room and between patients undergoing surgery.

Full description

The purpose of this study is to prevent the spread of S. aureus, a dangerous bacterium, within the operating room and between patients undergoing surgery. The investigators will combine several approaches in a "bundle" of activities to achieve this goal. The bundle will include removal of bacterial pathogens from patient skin sites before surgery, from provider hands before, during, and after surgery, from environmental surfaces before and after terminal cleaning, and from the injection ports of patient intravenous catheters. The investigators will use a new surveillance system to evaluate how well the bundle, and each component of the bundle, is working. Surveillance will identify S. aureus transmission events, and movement of S. aureus between reservoirs before, during, and after surgery (perioperative). Surveillance will map transmission events to identify actionable steps to improve the bundle. An infection control perioperative team will act on the surveillance reports to proactively address the action items, and to measure the effect of their efforts for the treatment group. The investigators will compare perioperative S. aureus transmission events for patients receiving the bundle to perioperative S. aureus transmission events for patients receiving usual care.

Enrollment

236 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • At least 18 years of age
  • Undergoing surgery (orthopedic total joint, orthopedic spine, Gynecological/Oncology, thoracic, general, hernia, colorectal, open vascular, plastic surgery and open urological)
  • Ability to sign informed consent
  • Require general or regional anesthesia

Exclusion criteria

  • Less than 18 years of age
  • Inability to sign informed consent
  • Procedures not included above
  • Not requiring general or regional anesthesia

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

236 participants in 2 patient groups

Standard of Care
No Intervention group
Description:
Patient will receive by mail a kit containing swab for the nares, armpit and groin.
Swab kit plus povidone-iodine soap
Active Comparator group
Description:
Patient will receive by mail a kit containing swab for the nares, armpit and groin. In addition the patient will receive decolonization treatment including povidone-iodine soap for presurgical cleansing two days prior to surgery.
Treatment:
Device: Swab and decolonization using povidone-iodine cleansing

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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