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

University of Alberta

Status and phase: Terminated; Phase 2

Conditions: INFECTION

Treatments: Other: No Vancomycin; Drug: Vancomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02374853

SWI-01-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,037 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1,037 participants in 2 patient groups, including a placebo group

Vancomycin

Experimental group

Description:

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

Treatment:

Drug: Vancomycin

Control

Placebo Comparator group

Description:

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

Treatment:

Other: No Vancomycin