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

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.

Study Overview

• Status: Terminated
• Conditions: INFECTION
• Intervention / Treatment: Drug: Vancomycin; Other: No Vancomycin

Detailed Description

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
• Enrollment (Actual): 1037
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vancomycin; During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in the following solution: 5 g vancomycin dissolved in 50 mL sterile water	Drug: Vancomycin; Topical prophylactic antibiotic; Other Names: Vancomycin Hydrochloride
Placebo Comparator: Control; During open heart surgery, patients will have a 4 x 8 inch piece of sterile gauze covering each side of the divided sternum. The gauze will be soaked in 50 mL sterile water. No Vancomycin	Other: No Vancomycin; Placebo: Sterile water. No Vancomycin.; Other Names: Sterile water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year postoperative
Hospitalization	Duration of index hospitalization and subsequent re-admissions due to sternal wound infection.	1 year postoperative
Number of Participants With Use of Prophylactic Antibiotics	Number of participants with use of prophylactic antibiotics before surgery	Assessed before surgery
Cost Analysis for Sternal Wound Infection Treatment	Cost analysis for sternal wound infection treatment post-operatively	1 year postoperative
Adverse Events	Adverse events during study participation	1 year postoperative

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Abbas Khani-Hanjani, MD, University of Alberta

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: SWI-01-14