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

Primary Purpose

INFECTION

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vancomycin
No Vancomycin
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for INFECTION

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Vancomycin

    Control

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 23, 2015
    Last Updated
    November 1, 2022
    Sponsor
    University of Alberta
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02374853
    Brief Title
    Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
    Acronym
    SWI
    Official Title
    Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Terminated
    Why Stopped
    the preliminary analysis of study result did not show significant benefit that was anticipate
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    April 2019 (Actual)
    Study Completion Date
    April 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Alberta

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    INFECTION

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    1037 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vancomycin
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    Vancomycin
    Other Intervention Name(s)
    Vancomycin Hydrochloride
    Intervention Description
    Topical prophylactic antibiotic
    Intervention Type
    Other
    Intervention Name(s)
    No Vancomycin
    Other Intervention Name(s)
    Sterile water
    Intervention Description
    Placebo: Sterile water. No Vancomycin.
    Primary Outcome Measure Information:
    Title
    Number of Sternal Wound Infections
    Description
    The number of sternal wound infections at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.
    Time Frame
    3 months postoperative
    Secondary Outcome Measure Information:
    Title
    Number of Sternal Wound Infections
    Description
    The number of sternal wound infections at 1 year postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.
    Time Frame
    1 year postoperative
    Title
    Hospitalization
    Description
    Duration of index hospitalization and subsequent re-admissions due to sternal wound infection.
    Time Frame
    1 year postoperative
    Title
    Number of Participants With Use of Prophylactic Antibiotics
    Description
    Number of participants with use of prophylactic antibiotics before surgery
    Time Frame
    Assessed before surgery
    Title
    Cost Analysis for Sternal Wound Infection Treatment
    Description
    Cost analysis for sternal wound infection treatment post-operatively
    Time Frame
    1 year postoperative
    Title
    Adverse Events
    Description
    Adverse events during study participation
    Time Frame
    1 year postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abbas Khani-Hanjani, MD
    Organizational Affiliation
    University of Alberta
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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