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

NCT ID: NCT02374853

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1037 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-04-30

Brief Summary

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.

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.

Conditions

INFECTION

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: DRUG

Topical prophylactic antibiotic

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

Group Type: PLACEBO_COMPARATOR

No Vancomycin

Intervention Type: OTHER

Placebo: Sterile water. No Vancomycin.

Interventions

Vancomycin

Topical prophylactic antibiotic

Intervention Type: DRUG

No Vancomycin

Placebo: Sterile water. No Vancomycin.

Intervention Type: OTHER

Other Intervention Names

Vancomycin Hydrochloride; Sterile water

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abbas Khani-Hanjani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SWI-01-14

Identifier Type: -

Identifier Source: org_study_id