Clinical trial NCT01425697: Eliminate Risk of Cardiac Surgical Site Events
Official title: Randomized,Prospective Evaluation of 2% Chlorhexidine Gluconate Cloths to Reduce Surgical Site Infections in Cardiothoracic Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infections
Keywords: Adult Cardiac surgery
Surgery site infections
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Sage Products, Inc.
First posted: 2011-08-30
Enrollment: 739
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Surgical site infections
timeFrame: Through 90 days post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: University of Rochester
name: Michael Ackerman, DNS
role: PRINCIPAL_INVESTIGATOR
References:
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
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
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.
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.
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.
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.
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.