- ICH GCP
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- Klinische proef NCT01629030
Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Seoul, Korea, republiek van, 135-710
- Werving
- Samsung Medical Center
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Onderonderzoeker:
- Sangmin M. Lee, MD, PhD
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Onderonderzoeker:
- Young Tak Lee, MD, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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postoperative surgical wound infection
Tijdsspanne: within first week after the end of coronary artery bypass graft surgery
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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
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within first week after the end of coronary artery bypass graft surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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preoperative total leukocyte count
Tijdsspanne: 1 day before surgery
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preoperative total leukocyte count
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1 day before surgery
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preoperative neutrophil count
Tijdsspanne: 1 day before surgery
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preoperative neutrophil count
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1 day before surgery
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preoperative lymphocyte count
Tijdsspanne: 1 day before surgery
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preoperative lymphocyte count
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1 day before surgery
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postoperative total leukocyte count
Tijdsspanne: 2 hour after the end of surgery
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postoprative total leukocyte count
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2 hour after the end of surgery
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postoperative neutrophil count
Tijdsspanne: 2 hour after the end of surgery
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postoperative neutrophil count
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2 hour after the end of surgery
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postoperative lymphocyte count
Tijdsspanne: 2 hour after the end of surgery
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postoperative lymphocyte count
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2 hour after the end of surgery
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preoperative NNIS risk index
Tijdsspanne: 1 day before surgery
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preoperative NNIS risk index
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1 day before surgery
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preoperative EuroScore
Tijdsspanne: 1 day before surgery
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preoperative EuroScore
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1 day before surgery
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Preoperative STS
Tijdsspanne: 1 day before surgery
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Preoperative STS (Society of Thoracic Surgeons risk score)
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1 day before surgery
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the incidence of surgical reopen with surgical wound infection
Tijdsspanne: within 1 month after surgery
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the incidence of surgical reopen with surgical wound infection
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within 1 month after surgery
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Won Ho Kim, MD, PhD, Samsung Medical Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2012-05-067-001
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