Surgical Site Infections
Conditions
Keywords
Adult Cardiac surgery, Surgery site infections
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.
Interventions
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.
OTHERStandard 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.
Sponsors
Sage Products, Inc.
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed