Eliminate Risk of Cardiac Surgical Site Events

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Site Infections

Intervention / Treatment
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* Other: 2% Chlorhexidine Gluconate cloths
* Other: Standard of Care preoperative preparation.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2% Chlorhexidine Gluconate cloths<br>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<br>* 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.<br>Other: Standard of Care preoperative preparation.<br>* 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.<br>|
| Other: Standard of Care Preoperative Preparation<br>Subject will receive standard of care preoperative preparation for the clinical site. | Other: 2% Chlorhexidine Gluconate cloths<br>* 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.<br>Other: Standard of Care preoperative preparation.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult Cardiac surgery, Surgery site infections