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Eliminate Risk of Cardiac Surgical Site Events (ERASE)

Primary Purpose

Surgical Site Infections

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

2% Chlorhexidine Gluconate cloths

Standard of Care preoperative preparation.

About this trial

This is an interventional prevention trial for Surgical Site Infections focused on measuring Adult Cardiac surgery, Surgery site infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Kentucky
The Valley Hospital
University of Rochester Medical Center
Robert Packer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

2% Chlorhexidine Gluconate cloths

Standard of Care Preoperative Preparation

Arm Description

2% Chlorhexidine Gluconate wipes will be used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery

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

Outcomes

Primary Outcome Measures

Surgical site infections

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01425697

First Posted

August 22, 2011

Last Updated

June 28, 2013

Sponsor

University of Rochester

Collaborators

Sage Products, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01425697

Brief Title

Eliminate Risk of Cardiac Surgical Site Events

Acronym

ERASE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

Sage Products, Inc.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Site Infections

Keywords

Adult Cardiac surgery, Surgery site infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

739 (Actual)

8. Arms, Groups, and Interventions

Arm Title

2% Chlorhexidine Gluconate cloths

Arm Type

Active Comparator

Arm Description

2% Chlorhexidine Gluconate wipes will be used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery

Arm Title

Standard of Care Preoperative Preparation

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

2% Chlorhexidine Gluconate cloths

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard of Care preoperative preparation.

Intervention Description

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 Outcome Measure Information:

Title

Surgical site infections

Description

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

Time Frame

Through 90 days post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Ackerman, DNS

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky

City

Lexington

State/Province

Kentucky

Country

United States

Facility Name

The Valley Hospital

City

Ridgewood

State/Province

New Jersey

Country

United States

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Robert Packer Hospital

City

Sayre

State/Province

Pennsylvania

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

result

Citation

Ryder M. Improving Skin Antisepsis: 2% no-rinse CHG cloths improve antiseptic persistence on patient skin over 4% CHG rinse-off solution. Poster, accepted for presentation at:Association for Professionals in Infection Control and Epidemiology (APIC) June 2007

Results Reference

result

PubMed Identifier

17327187

Citation

Edmiston CE Jr, Seabrook GR, Johnson CP, Paulson DS, Beausoleil CM. Comparative of a new and innovative 2% chlorhexidine gluconate-impregnated cloth with 4% chlorhexidine gluconate as topical antiseptic for preparation of the skin prior to surgery. Am J Infect Control. 2007 Mar;35(2):89-96. doi: 10.1016/j.ajic.2006.06.012.

Results Reference

result

Citation

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.

Results Reference

result

Citation

Eiselt D. Presurgical skin preparation with a novel 2% chlorhexidine gluconate (CHG) cloth leads to decrease in surgical site infection rates in orthopedic surgical patients. Poster accepted for presentation at: Association for Professionals in Infection Control and Epidemiology (APIC) June 2007.

Results Reference

result

Citation

Rhee H, Harris B. Reducing surgical site infection: 2% CHG cloth reduces SSI rates by >70% difference resulting in a $154,869 cost avoidance. Poster accepted for presentation at: Virginians Improving Patient Care and Safety (VIPC&S) 7th Annual Conference.

Results Reference

result

PubMed Identifier

6177735

Citation

Berry AR, Watt B, Goldacre MJ, Thomson JW, McNair TJ. A comparison of the use of povidone-iodine and chlorhexidine in the prophylaxis of postoperative wound infection. J Hosp Infect. 1982 Mar;3(1):55-63. doi: 10.1016/0195-6701(82)90031-7. No abstract available.

Results Reference

result

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Eliminate Risk of Cardiac Surgical Site Events

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