Study Stopped
the preliminary analysis of study result did not show significant benefit that was anticipate
Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
SWI
1 other identifier
interventional
1,037
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2015
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedResults Posted
Study results publicly available
November 3, 2022
CompletedNovember 3, 2022
August 1, 2022
4.1 years
February 23, 2015
August 17, 2022
November 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Number of Sternal Wound Infections
1 year postoperative
Hospitalization
1 year postoperative
Number of Participants With Use of Prophylactic Antibiotics
Assessed before surgery
Cost Analysis for Sternal Wound Infection Treatment
1 year postoperative
Adverse Events
1 year postoperative
Study Arms (2)
Vancomycin
EXPERIMENTALDuring 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
Control
PLACEBO COMPARATORDuring 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
Interventions
Eligibility Criteria
You may qualify if:
- Able to sign Informed Consent and Release of Medical Information Form
- Age ≥ 18 years
- Undergoing cardiac surgery with complete sternotomy (including re-operations)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. John Mullen
- Organization
- University of Alberta
Study Officials
- PRINCIPAL INVESTIGATOR
Abbas Khani-Hanjani, MD
University of Alberta
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2015
First Posted
March 2, 2015
Study Start
March 1, 2015
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
November 3, 2022
Results First Posted
November 3, 2022
Record last verified: 2022-08