Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft

This study is currently recruiting participants.
Verified June 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Sangmin M. Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01629030
First received: June 25, 2012
Last updated: June 26, 2012
Last verified: June 2012

June 25, 2012
June 26, 2012
June 2012
May 2013   (final data collection date for primary outcome measure)
postoperative surgical wound infection [ Time Frame: within first week after the end of coronary artery bypass graft surgery ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01629030 on ClinicalTrials.gov Archive Site
  • preoperative total leukocyte count [ Time Frame: 1 day before surgery ] [ Designated as safety issue: No ]
    preoperative total leukocyte count
  • preoperative neutrophil count [ Time Frame: 1 day before surgery ] [ Designated as safety issue: No ]
    preoperative neutrophil count
  • preoperative lymphocyte count [ Time Frame: 1 day before surgery ] [ Designated as safety issue: No ]
    preoperative lymphocyte count
  • postoperative total leukocyte count [ Time Frame: 2 hour after the end of surgery ] [ Designated as safety issue: No ]
    postoprative total leukocyte count
  • postoperative neutrophil count [ Time Frame: 2 hour after the end of surgery ] [ Designated as safety issue: No ]
    postoperative neutrophil count
  • postoperative lymphocyte count [ Time Frame: 2 hour after the end of surgery ] [ Designated as safety issue: No ]
    postoperative lymphocyte count
  • preoperative NNIS risk index [ Time Frame: 1 day before surgery ] [ Designated as safety issue: No ]
    preoperative NNIS risk index
  • preoperative EuroScore [ Time Frame: 1 day before surgery ] [ Designated as safety issue: No ]
    preoperative EuroScore
  • Preoperative STS [ Time Frame: 1 day before surgery ] [ Designated as safety issue: No ]
    Preoperative STS (Society of Thoracic Surgeons risk score)
  • the incidence of surgical reopen with surgical wound infection [ Time Frame: within 1 month after surgery ] [ Designated as safety issue: No ]
    the incidence of surgical reopen with surgical wound infection
Same as current
Not Provided
Not Provided
 
Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft

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.

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.

Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Coronary Artery Bypass Graft
  • Median Sternotomy
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1850
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 90 Years
No
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
Korea, Republic of
 
NCT01629030
2012-05-067-001
No
Sangmin M. Lee, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Sangmin M. Lee, MD, PhD Samsung Medical Center
Principal Investigator: Won Ho Kim, MD, PhD Samsung Medical Center
Samsung Medical Center
June 2012

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