ERASE: Eliminate Risk of Cardiac Surgical Site Events

Sponsor

University of Rochester (Other)

Overall Status

Completed

CT.gov ID

NCT01425697

Collaborator

Sage Products, Inc. (Industry)

739

Enrollment

Locations

Arms

Duration (Months)

184.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Surgical Site Infections	Other: 2% Chlorhexidine Gluconate cloths Other: Standard of Care preoperative preparation.	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

739 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.
Other: 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.

Arm

Intervention/Treatment

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.

Other: Standard of Care Preoperative Preparation

Subject will receive standard of care preoperative preparation for the clinical site.

Other: 2% Chlorhexidine Gluconate cloths

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.

Outcome Measures

Primary Outcome Measures

Surgical site infections [Through 90 days post procedure]
Subjects will be assessed at 30 days and 90 days post operatively for any surgical site infection

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States
2	The Valley Hospital	Ridgewood	New Jersey	United States
3	University of Rochester Medical Center	Rochester	New York	United States	14642
4	Robert Packer Hospital	Sayre	Pennsylvania	United States