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

INFECTION Clinical Trial

— SWI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02374853
• Other study ID #: SWI-01-14
• Status: Terminated
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: April 2019

Study information

• Verified date: August 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1037
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• INFECTION
• Infections
• Wound Infection

Intervention

Drug:
• Vancomycin
Topical prophylactic antibiotic

Other:
• No Vancomycin
Placebo: Sterile water. No Vancomycin.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Outcome

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