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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Bypass Graft; Median Sternotomy

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 Type: Observational
• Enrollment (Anticipated): 1850

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Sub-Investigator: Sangmin M. Lee, MD, PhD
    • Sub-Investigator: Young Tak Lee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative surgical wound infection	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	within first week after the end of coronary artery bypass graft surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperative total leukocyte count	preoperative total leukocyte count	1 day before surgery
preoperative neutrophil count	preoperative neutrophil count	1 day before surgery
preoperative lymphocyte count	preoperative lymphocyte count	1 day before surgery
postoperative total leukocyte count	postoprative total leukocyte count	2 hour after the end of surgery
postoperative neutrophil count	postoperative neutrophil count	2 hour after the end of surgery
postoperative lymphocyte count	postoperative lymphocyte count	2 hour after the end of surgery
preoperative NNIS risk index	preoperative NNIS risk index	1 day before surgery
preoperative EuroScore	preoperative EuroScore	1 day before surgery
Preoperative STS	Preoperative STS (Society of Thoracic Surgeons risk score)	1 day before surgery
the incidence of surgical reopen with surgical wound infection	the incidence of surgical reopen with surgical wound infection	within 1 month after surgery

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Won Ho Kim, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 27, 2012

Study Record Updates

• Last Update Posted (Estimate): July 9, 2014
• Last Update Submitted That Met QC Criteria: July 8, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: coronary artery bypass graft; risk factor; sternal wound infection
• Additional Relevant MeSH Terms: Infections; Wound Infection
• Other Study ID Numbers: 2012-05-067-001