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Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft

8. juli 2014 opdateret af: Sangmin M. Lee, Samsung Medical Center
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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

1850

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
      • Seoul, Korea, Republikken, 135-710
        • Rekruttering
        • Samsung Medical Center
        • Underforsker:
          • Sangmin M. Lee, MD, PhD
        • Underforsker:
          • Young Tak Lee, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
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
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samsung Medical Center

Efterforskere

  • Ledende efterforsker: Won Ho Kim, MD, PhD, Samsung Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Forventet)

1. december 2014

Studieafslutning (Forventet)

1. december 2014

Datoer for studieregistrering

Først indsendt

25. juni 2012

Først indsendt, der opfyldte QC-kriterier

26. juni 2012

Først opslået (Skøn)

27. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2014

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2012-05-067-001

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Koronararterie Bypass-graft

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Thailand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner