NCT01425697

Eliminate Risk of Cardiac Surgical Site Events

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 739 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgical Site Infections

Interventions

Type	Name	Description
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.
OTHER	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.

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-07-01
• Completion: 2012-09-01
• First posted: 2011-08-30
• Last updated: 2013-07-02

Locations

4 sites across 1 country: United States