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Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Sangmin M. Lee, Samsung Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01629030
First Posted: June 27, 2012
Last Update Posted: July 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sangmin M. Lee, Samsung Medical Center
  Purpose
The investigators are trying to evaluate the performance of neutrophil and lymphocyte counts as a risk factor of deep sternal wound infection after coronary artery bypass graft surgery.

Condition
Coronary Artery Bypass Graft Median Sternotomy

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft

Resource links provided by NLM:


Further study details as provided by Sangmin M. Lee, Samsung Medical Center:

Primary Outcome Measures:
  • postoperative surgical wound infection [ Time Frame: within first week after the end of coronary artery bypass graft surgery ]
    postoperative surgical wound infection within first week after the end of coronary artery bypass graft surgery, classified as a superfical or deep sternal wound infection


Secondary Outcome Measures:
  • preoperative total leukocyte count [ Time Frame: 1 day before surgery ]
    preoperative total leukocyte count

  • preoperative neutrophil count [ Time Frame: 1 day before surgery ]
    preoperative neutrophil count

  • preoperative lymphocyte count [ Time Frame: 1 day before surgery ]
    preoperative lymphocyte count

  • postoperative total leukocyte count [ Time Frame: 2 hour after the end of surgery ]
    postoprative total leukocyte count

  • postoperative neutrophil count [ Time Frame: 2 hour after the end of surgery ]
    postoperative neutrophil count

  • postoperative lymphocyte count [ Time Frame: 2 hour after the end of surgery ]
    postoperative lymphocyte count

  • preoperative NNIS risk index [ Time Frame: 1 day before surgery ]
    preoperative NNIS risk index

  • preoperative EuroScore [ Time Frame: 1 day before surgery ]
    preoperative EuroScore

  • Preoperative STS [ Time Frame: 1 day before surgery ]
    Preoperative STS (Society of Thoracic Surgeons risk score)

  • the incidence of surgical reopen with surgical wound infection [ Time Frame: within 1 month after surgery ]
    the incidence of surgical reopen with surgical wound infection


Estimated Enrollment: 1850
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coronary Artery Bypass Graft Group
Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.

Detailed Description:

Deep sternal wound infection after coronary artery bypass graft is a very dangerous complication as it prolongs hospital stay, increase morbidity and mortality, and increase cost of care.

As a risk factor of surgical site infection, risk index reported by NNIS (national nosocomial infection surveillance), Euroscore, or Society of thoracic surgeon risk score are currently used. However, as various performances are reported regarding these index or scoring systems, and many factors are needed for these index or scoring system, there is a need to develop a more simple risk factor with better performance. We focused on the differential blood cell count, as the neutrophil and lymphocyte count are related to the degree of surgical invasion, and inflammatory response. Previous studies reported that the neutrophilia or lymphopenia is related to postoperative infection. Therefore, we are trying to evaluate the performance of preoperative or postoperative the blood cell differential count as a risk factor for sternal wound infection after coronary artery bypass surgery.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.
Criteria

Inclusion Criteria:

  • Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.

Exclusion Criteria:

  • Those underwent coronary artery bypass graft surgery with mini-thoracotomy
  • Those with insufficient study data recognized by electronic medical record
  Contacts and Locations
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): NCT01629030


Contacts
Contact: Sangmin M. Lee, MD, PhD 82-2-3410-0362 sangminm.lee@samsung.com
Contact: Won Ho Kim, MD 82-2-3410-1994 bullet57@naver.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Sangmin M. Lee, MD, PhD    82-2-3410-0362    sangminm.lee@samsung.com   
Contact: Won Ho Kim, MD    82-2-3410-1994    bullet57@naver.com   
Sub-Investigator: Sangmin M. Lee, MD, PhD         
Sub-Investigator: Young Tak Lee, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Sangmin M. Lee, MD, PhD Samsung Medical Center
Principal Investigator: Won Ho Kim, MD, PhD Samsung Medical Center
  More Information

Responsible Party: Sangmin M. Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01629030     History of Changes
Other Study ID Numbers: 2012-05-067-001
First Submitted: June 25, 2012
First Posted: June 27, 2012
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by Sangmin M. Lee, Samsung Medical Center:
sternal wound infection
coronary artery bypass graft
risk factor

Additional relevant MeSH terms:
Infection
Wound Infection