- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01629030
Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
Studieoversikt
Status
Detaljert beskrivelse
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
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
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Seoul, Korea, Republikken, 135-710
- Rekruttering
- Samsung Medical Center
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Underetterforsker:
- Sangmin M. Lee, MD, PhD
-
Underetterforsker:
- Young Tak Lee, MD, PhD
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
postoperative surgical wound infection
Tidsramme: 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
|
within first week after the end of coronary artery bypass graft surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
preoperative total leukocyte count
Tidsramme: 1 day before surgery
|
preoperative total leukocyte count
|
1 day before surgery
|
|
preoperative neutrophil count
Tidsramme: 1 day before surgery
|
preoperative neutrophil count
|
1 day before surgery
|
|
preoperative lymphocyte count
Tidsramme: 1 day before surgery
|
preoperative lymphocyte count
|
1 day before surgery
|
|
postoperative total leukocyte count
Tidsramme: 2 hour after the end of surgery
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postoprative total leukocyte count
|
2 hour after the end of surgery
|
|
postoperative neutrophil count
Tidsramme: 2 hour after the end of surgery
|
postoperative neutrophil count
|
2 hour after the end of surgery
|
|
postoperative lymphocyte count
Tidsramme: 2 hour after the end of surgery
|
postoperative lymphocyte count
|
2 hour after the end of surgery
|
|
preoperative NNIS risk index
Tidsramme: 1 day before surgery
|
preoperative NNIS risk index
|
1 day before surgery
|
|
preoperative EuroScore
Tidsramme: 1 day before surgery
|
preoperative EuroScore
|
1 day before surgery
|
|
Preoperative STS
Tidsramme: 1 day before surgery
|
Preoperative STS (Society of Thoracic Surgeons risk score)
|
1 day before surgery
|
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the incidence of surgical reopen with surgical wound infection
Tidsramme: within 1 month after surgery
|
the incidence of surgical reopen with surgical wound infection
|
within 1 month after surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Won Ho Kim, MD, PhD, Samsung Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2012-05-067-001
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