Eliminate Risk of Cardiac Surgical Site Events (ERASE)

This study has been completed.
Sponsor:
Collaborator:
Sage Products, Inc.
Information provided by (Responsible Party):
Michael Ackerman, University of Rochester
ClinicalTrials.gov Identifier:
NCT01425697
First received: August 22, 2011
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Surgical Site Infections
Other: 2% Chlorhexidine Gluconate cloths
Other: Standard of Care preoperative preparation.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized,Prospective Evaluation of 2% Chlorhexidine Gluconate Cloths to Reduce Surgical Site Infections in Cardiothoracic Surgery Patients

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Surgical site infections [ Time Frame: Through 90 days post procedure ] [ Designated as safety issue: No ]
    Subjects will be assessed at 30 days and 90 days post operatively for any surgical site infection


Enrollment: 739
Study Start Date: November 2008
Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2% Chlorhexidine Gluconate cloths
2% Chlorhexidine Gluconate wipes will be used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery
Other: 2% Chlorhexidine Gluconate cloths
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.
Other: Standard of Care preoperative preparation.
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.
Standard of Care Preoperative Preparation
Subject will receive standard of care preoperative preparation for the clinical site.
Other: 2% Chlorhexidine Gluconate cloths
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.
Other: Standard of Care preoperative preparation.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425697

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States
United States, New Jersey
The Valley Hospital
Ridgewood, New Jersey, United States
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Pennsylvania
Robert Packer Hospital
Sayre, Pennsylvania, United States
Sponsors and Collaborators
University of Rochester
Sage Products, Inc.
Investigators
Principal Investigator: Michael Ackerman, DNS University of Rochester
  More Information

Publications:
DeBaun B. Evaluation of the antimicrobial properties of an alcohol-free 2% chlorhexidine gluconate (CHG) solution. Poster, accepted for presentation at: 2007 Association of perioperative registered nurses (AORN) Congress, Orlando, FL Mar 2007
Edmiston C, Seabrook GR, Johnson CP, et al. Comparison of a new and innovative 2% chlorhexidine gluconate (CHG) impregnated preparation cloth with the standard 4% CHG surgical skin preparation. Poster, accepted for presentation at: 2007 Association of perioperative Registered Nurses (AORN) Congress, Orlando, FL Mar 2007.

Responsible Party: Michael Ackerman, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01425697     History of Changes
Other Study ID Numbers: RSRB 25962
Study First Received: August 22, 2011
Last Updated: June 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Adult Cardiac surgery
Surgery site infections

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on August 21, 2014