Clinical trial NCT01629030: Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
Official title: Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Bypass Graft
Median Sternotomy
Keywords: sternal wound infection
coronary artery bypass graft
risk factor
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 1850
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: postoperative surgical wound infection
timeFrame: within first week after the end of coronary artery bypass graft surgery
Secondary outcomes:
measure: preoperative total leukocyte count
timeFrame: 1 day before surgery
measure: preoperative neutrophil count
timeFrame: 1 day before surgery
measure: preoperative lymphocyte count
timeFrame: 1 day before surgery
measure: postoperative total leukocyte count
timeFrame: 2 hour after the end of surgery
measure: postoperative neutrophil count
timeFrame: 2 hour after the end of surgery
measure: postoperative lymphocyte count
timeFrame: 2 hour after the end of surgery
measure: preoperative NNIS risk index
timeFrame: 1 day before surgery
measure: preoperative EuroScore
timeFrame: 1 day before surgery
measure: Preoperative STS
timeFrame: 1 day before surgery
measure: the incidence of surgical reopen with surgical wound infection
timeFrame: within 1 month after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Sangmin M. Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Won Ho Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: