Eliminate Risk of Cardiac Surgical Site Events (ERASE)

University of Rochester

Status: Completed

Conditions: Surgical Site Infections

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01425697

RSRB 25962

Details and patient eligibility

About

The purpose of the study is to see if using 2% Chlorhexidine cloths will reduce surgical site infections in patients having elective cardiac surgery.

Full 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.

Enrollment: 739 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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739 participants in 2 patient groups

2% Chlorhexidine Gluconate cloths

Active Comparator group

Description:

2% Chlorhexidine Gluconate wipes will be used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery

Treatment:

Other: Standard of Care preoperative preparation.

Other: 2% Chlorhexidine Gluconate cloths

Standard of Care Preoperative Preparation

Other group

Description:

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

Treatment:

Other: Standard of Care preoperative preparation.

Other: 2% Chlorhexidine Gluconate cloths