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Completed

NCT Number: NCT01425697

Eliminate Risk of Cardiac Surgical Site Events

The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical site infections in patients having elective cardiac surgery.

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Key information

Conditions

Surgical Site Infections Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky, Lexington, Kentucky, United States

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About this study

A randomized, prospective study utilizing 2% Chlorhexidine cloths to evaluate the product's effectiveness in reducing surgical site infections in elective cardiothoracic surgery patients. Sage 2% chlorhexidine cloths are approved by the Food and Drug Administration (FDA) for preparation of skin prior to surgery.

The study hypothesis is that the preoperative surgical preparation with 2% chlorhexidine cloths, which leaves chlorhexidine on the skin, will reduce surgical site infections by 50% as compared to current standard procedure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective cardiothoracic surgery patients > 18 years old.
  • Informed consent obtained

Exclusion criteria

  • Any current known allergies to chlorhexidine gluconate
  • Currently taking any oral or topical antibiotics
  • Any active skin rashes or breaks in the skin on areas to be treated with chlorhexidine gluconate
  • A current active skin disease or inflammatory skin condition, known pre-existing skin infection, including contact dermatitis that is currently being treated with an antibiotic
  • Any medical condition or use of any medications that in the opinion of the Principal Investigator preclude participation.
  • Unwillingness or failure to fulfill requirements of the study

Treatment and study plan

2% Chlorhexidine Gluconate cloths

Other

2% chlorhexidine Gluconate wipes will bw used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery. Subjects will be randomized to either receive a preoperative phone call reminder or no phone call reminder.

Standard of Care preoperative preparation.

Other

Preoperative standard of care preparation utilized at the clinical site will be used. Subjects will be randomized to either receive a preoperative phone call reminder or no phone call reminder.

Primary outcomes

  1. Surgical site infections

    Time frame: Through 90 days post procedure

    Subjects will be assessed at 30 days and 90 days post operatively for any surgical site infection

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Sage Products, Inc.

Registry information

Official study title

Randomized,Prospective Evaluation of 2% Chlorhexidine Gluconate Cloths to Reduce Surgical Site Infections in Cardiothoracic Surgery Patients

Acronym: ERASE

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 30, 2011
Registry last updated
Jul 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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