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

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ClinicalTrials.gov Identifier: NCT02374853
Recruitment Status : Terminated (the preliminary analysis of study result did not show significant benefit that was anticipate)
First Posted : March 2, 2015
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Abbas Khani-Hanjani, University of Alberta

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.

Condition or disease Intervention/treatment Phase
INFECTION Drug: Vancomycin Other: No Vancomycin Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 894 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
Study Start Date : March 2015
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Vancomycin
Topical prophylactic antibiotic
Other Name: Vancomycin Hydrochloride

Placebo Comparator: 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
Other: No Vancomycin
Placebo: Sterile water. No Vancomycin.
Other Name: Sterile water




Primary Outcome Measures :
  1. Incidence of sternal wound infection [ Time Frame: 3 months postoperative ]
    The primary endpoint of this trial is the incidence of sternal wound infection at 3 months postoperative. This includes superficial incisional, deep incisional, and organ/space surgical site infections.


Secondary Outcome Measures :
  1. Incidence of sternal wound infection [ Time Frame: 1 year postoperative ]
  2. Hospitalization [ Time Frame: 1 year postoperative ]
    Duration of index hospitalization and subsequent re-admissions due to sternal wound infection.

  3. Use of prophylactic antibiotics [ Time Frame: 1 year postoperative ]
  4. Cost analysis for sternal wound infection treatment [ Time Frame: 1 year postoperative ]
  5. Adverse events [ Time Frame: 1 year postoperative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374853


Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Abbas Khani-Hanjani, MD University of Alberta

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Responsible Party: Abbas Khani-Hanjani, Clinical Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02374853     History of Changes
Other Study ID Numbers: SWI-01-14
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents