Eliminate Risk of Cardiac Surgical Site Events

Surgical Site Infections Clinical Trial

— ERASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425697
• Other study ID #: RSRB 25962
• Status: Completed
• Phase: N/A
• First received: August 22, 2011
• Last updated: June 28, 2013
• Start date: November 2008
• Est. completion date: September 2012

Study information

• Verified date: June 2013
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 739
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Surgical Site Infections
• Surgical Wound Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky
United States	The Valley Hospital	Ridgewood	New Jersey
United States	University of Rochester Medical Center	Rochester	New York
United States	Robert Packer Hospital	Sayre	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Sage Products, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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

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 per

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 I — View 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

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.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infections	Subjects will be assessed at 30 days and 90 days post operatively for any surgical site infection	Through 90 days post procedure	No