Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft

• Conditions: Coronary Artery Bypass Graft; Median Sternotomy

• Registration Number: NCT01629030
• Lead Sponsor: Samsung Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-09
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1850

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.

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Exclusion Criteria

• Those underwent coronary artery bypass graft surgery with mini-thoracotomy
• Those with insufficient study data recognized by electronic medical record

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of