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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

Tracking Information
First Submitted Date  ICMJE February 23, 2015
First Posted Date  ICMJE March 2, 2015
Last Update Posted Date April 25, 2019
Study Start Date  ICMJE March 2015
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02374853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
  • Incidence of sternal wound infection [ Time Frame: 1 year postoperative ]
  • Hospitalization [ Time Frame: 1 year postoperative ]
    Duration of index hospitalization and subsequent re-admissions due to sternal wound infection.
  • Use of prophylactic antibiotics [ Time Frame: 1 year postoperative ]
  • Cost analysis for sternal wound infection treatment [ Time Frame: 1 year postoperative ]
  • Adverse events [ Time Frame: 1 year postoperative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
Official Title  ICMJE Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE INFECTION
Intervention  ICMJE
  • Drug: Vancomycin
    Topical prophylactic antibiotic
    Other Name: Vancomycin Hydrochloride
  • Other: No Vancomycin
    Placebo: Sterile water. No Vancomycin.
    Other Name: Sterile water
Study Arms  ICMJE
  • 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
    Intervention: Drug: Vancomycin
  • 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
    Intervention: Other: No Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 23, 2019)
894
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2015)
1552
Actual Study Completion Date  ICMJE April 2019
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02374853
Other Study ID Numbers  ICMJE SWI-01-14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbas Khani-Hanjani, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abbas Khani-Hanjani, MD University of Alberta
PRS Account University of Alberta
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP