Eliminate Risk of Cardiac Surgical Site Events

NCT01425697 | Completed

• 1 other identifier: RSRB 25962
• Study Type: interventional
• Target: 739
• Locations: 1 country
• Sites: 4

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.

Conditions

Surgical Site Infections

Keywords

Adult Cardiac surgery; Surgery site infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

2% Chlorhexidine Gluconate cloths

ACTIVE COMPARATOR

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; Other: Standard of Care preoperative preparation.

Standard of Care Preoperative Preparation

OTHER

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

Other: 2% Chlorhexidine Gluconate cloths; Other: Standard of Care preoperative preparation.

Interventions

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.

2% Chlorhexidine Gluconate cloths; Standard of Care Preoperative Preparation

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.

2% Chlorhexidine Gluconate cloths; Standard of Care Preoperative Preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Sage Products, Inc.: collaborator

Study Sites (4)

University of Kentucky

Lexington, Kentucky, United States

Location

The Valley Hospital

Ridgewood, New Jersey, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Robert Packer Hospital

Sayre, Pennsylvania, United States

Location

Related Publications (7)

• 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

  RESULT

• 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

  RESULT

• 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.

  PMID: 17327187 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 6177735 RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Ackerman, DNS

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 30, 2011
• Study Start: November 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 2, 2013

Record last verified: 2013-06

Locations

US (4)