Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft

Sponsor
Samsung Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01629030
Collaborator
(none)
1,850
1
30
61.7

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1850 participants
    Time Perspective:
    Retrospective
    Official Title:
    Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
    Study Start Date :
    Jun 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2014
    Anticipated Study Completion Date :
    Dec 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. postoperative surgical wound infection [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

    1. preoperative total leukocyte count [1 day before surgery]

      preoperative total leukocyte count

    2. preoperative neutrophil count [1 day before surgery]

      preoperative neutrophil count

    3. preoperative lymphocyte count [1 day before surgery]

      preoperative lymphocyte count

    4. postoperative total leukocyte count [2 hour after the end of surgery]

      postoprative total leukocyte count

    5. postoperative neutrophil count [2 hour after the end of surgery]

      postoperative neutrophil count

    6. postoperative lymphocyte count [2 hour after the end of surgery]

      postoperative lymphocyte count

    7. preoperative NNIS risk index [1 day before surgery]

      preoperative NNIS risk index

    8. preoperative EuroScore [1 day before surgery]

      preoperative EuroScore

    9. Preoperative STS [1 day before surgery]

      Preoperative STS (Society of Thoracic Surgeons risk score)

    10. the incidence of surgical reopen with surgical wound infection [within 1 month after surgery]

      the incidence of surgical reopen with surgical wound infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 135-710

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sangmin M. Lee, Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01629030
    Other Study ID Numbers:
    • 2012-05-067-001
    First Posted:
    Jun 27, 2012
    Last Update Posted:
    Jul 9, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Sangmin M. Lee, Professor, Samsung Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 9, 2014