Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)

Phase 2TerminatedNCT02374853

University of Alberta1,037 enrolled

Overview

The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection.

During open-heart surgery, an incision is made along the chest and the sternum (breastbone) is divided. The sternum is held open throughout the surgery so that the doctors can reach the heart. Sternal wound infection is an uncommon but serious complication of cardiac surgery that occurs when an infection develops at this site of entry. Sternal wound infections are associated with increased hospital stays, subsequent surgical procedures, and higher mortality rates. The purpose of this research is to determine if using the antibiotic vancomycin as a preventative topical (on the surface of the skin) treatment during open-heart surgery will reduce the risk of developing a sternal wound infection. The results of this study could provide important information to guide new standards of practice in cardiac surgery. The ultimate goal of this research project is to improve patient care by reducing the number of sternal wound infections at our hospital.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,037

Conditions

INFECTION

Interventions

VancomycinDRUG

Topical prophylactic antibiotic

No VancomycinOTHER

Placebo: Sterile water. No Vancomycin.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Able to sign Informed Consent and Release of Medical Information Form * Age ≥ 18 years * Undergoing cardiac surgery with complete sternotomy (including re-operations) Exclusion Criteria: * Evidence of active infection (any culture positive or blood positive infection) * Undergoing organ transplantation * Patients with known hypersensitivity to vancomycin * Pregnant or nursing women * Mental impairment or other conditions that may not allow participant to understand the nature, significance, and scope of study

Outcomes

Primary Outcomes

Number of Sternal Wound Infections

The number of sternal wound infections at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.

Time frame: 3 months postoperative

Secondary Outcomes

Number of Sternal Wound Infections

The number of sternal wound infections at 1 year postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.

Time frame: 1 year postoperative

Hospitalization

Duration of index hospitalization and subsequent re-admissions due to sternal wound infection.

Time frame: 1 year postoperative

Number of Participants With Use of Prophylactic Antibiotics

Number of participants with use of prophylactic antibiotics before surgery

Time frame: Assessed before surgery

Cost Analysis for Sternal Wound Infection Treatment

Cost analysis for sternal wound infection treatment post-operatively

Time frame: 1 year postoperative

Adverse Events

Adverse events during study participation

Time frame: 1 year postoperative

Data from ClinicalTrials.gov

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