Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft

Coronary Artery Bypass Graft Clinical Trial

Official title:

Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01629030
• Other study ID #: 2012-05-067-001
• Status: Recruiting
• Phase: N/A
• First received: June 25, 2012
• Last updated: July 8, 2014
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2014
• Source: Samsung Medical Center
• Contact: Sangmin M. Lee, MD, PhD
• Phone: 82-2-3410-0362
• Email: sangminm.lee[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1850
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft
• Median Sternotomy
• Wound Infection

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	preoperative total leukocyte count	preoperative total leukocyte count	1 day before surgery	No
Secondary	preoperative neutrophil count	preoperative neutrophil count	1 day before surgery	No
Secondary	preoperative lymphocyte count	preoperative lymphocyte count	1 day before surgery	No
Secondary	postoperative total leukocyte count	postoprative total leukocyte count	2 hour after the end of surgery	No
Secondary	postoperative neutrophil count	postoperative neutrophil count	2 hour after the end of surgery	No
Secondary	postoperative lymphocyte count	postoperative lymphocyte count	2 hour after the end of surgery	No
Secondary	preoperative NNIS risk index	preoperative NNIS risk index	1 day before surgery	No
Secondary	preoperative EuroScore	preoperative EuroScore	1 day before surgery	No
Secondary	Preoperative STS	Preoperative STS (Society of Thoracic Surgeons risk score)	1 day before surgery	No
Secondary	the incidence of surgical reopen with surgical wound infection	the incidence of surgical reopen with surgical wound infection	within 1 month after surgery	No