Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery (EURIDICE)
9. maj 2012 opdateret af: Pfizer
A Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
This is an observational study to evaluate the relative importance of the known risk factors for severe surgical site infections (SSIs) on the development of the more severe SSI cases, and to describe the demographic, clinical features, etiology and the management and outcome of patients suffering from severe SSIs in Spain.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Case and Control study.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
180
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with or without surgical site infections (SSI) after surgery, treated in major hospitals with general surgical units selected from all over Spain
Beskrivelse
Inclusion Criteria:
- Age of or above 18 years.
- Admitted to a General Surgery Ward for elective or emergency abdominal surgery.
- Contaminated or dirty-infected surgical procedures.
- Only for cases, they will have to present symptoms and signs of a surgical site infection (SSI) (within 0-30 days) after abdominal surgery.
- Only for controls, patients must be free of SSI after 30 days from surgery, regardless of whether they are still in the hospital or being observed as an outpatient in the external clinic.
Exclusion Criteria:
- Age under 18 years.
- American Society of Anesthesiologist (ASA) score of 5 or above.
- Surgical implant in place.
- Clean or clean-contaminated surgical procedures.
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 |
Intervention / Behandling |
|---|---|
|
Case
Cases will be defined as patients with elective or emergency abdominal surgery who develop severe surgical site infection (deep incisional or organ cavity type; see Center for Disease Control (CDC) criteria for definition in the Appendix), within 0-30 days of surgery.
|
Clinical record review.
Clinical record review
|
|
Control
Surgeon-matched controls will be patients with elective or emergency abdominal surgery who are free of surgical site infection (SSI) after 30 days from the surgery.
|
Clinical record review.
Clinical record review
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With Pre-surgical Morbidities
Tidsramme: Baseline (Pre-surgical)
|
Morbidities (risk factors) included: neoplasm, tobacco use, body mass index (weight in kilograms divided by height in meters squared [BMI kg/m2]) greater than (>) 30, diabetes mellitus (DM), immunosuppression/ corticosteroids, anemia (hemoglobin [Hb] less than (>) 9 grams per deciliter [gr/dL]) or malnutrition (hypoalbuminemia).
|
Baseline (Pre-surgical)
|
|
Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis
Tidsramme: Baseline (Pre-surgical)
|
Baseline (Pre-surgical)
|
|
|
Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery
Tidsramme: Day 0 (day of surgery)
|
Day 0 (day of surgery)
|
|
|
Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty
Tidsramme: Day 0 (day of surgery)
|
Surgical infection risk class: Clean-contaminated: controlled entry in normally colonized body cavities/no unusual contamination/minimum fluid discharge/minimal sterile technique violation/re-surgery on clean surgical incision within 7 days/negative surgical exploration through intact skin.
Contaminated: no acute inflammation/purulent discharge/significant fluid/material violation of sterile technique/penetrating trauma less than 4 hours old/graft in chronic skin wounds.
Dirty: pus-abscess drainage/ preoperatively colonized body cavity perforated/penetrating trauma more than 4 hours old.
|
Day 0 (day of surgery)
|
|
Type of Surgeon
Tidsramme: Day 0 (day of surgery)
|
Surgical speciality of physician who performed surgery.
|
Day 0 (day of surgery)
|
|
Percentage of Participants With Infection
Tidsramme: Day 0 (day of surgery) up to 30 days post surgery
|
Microorganism infection by bacterial type.
|
Day 0 (day of surgery) up to 30 days post surgery
|
|
Percentage of Participants Who Showed Clinical Improvement of SSI
Tidsramme: Day 0 (day of surgery) up to 30 days post surgery
|
Clinical improvement of SSI was defined as healed (signs and symptoms of initial infection resolved) or improved (initial signs and symptoms significantly diminished without the appearance of new signs).
|
Day 0 (day of surgery) up to 30 days post surgery
|
|
Percentage of Participants With Post-surgical Drainage
Tidsramme: Day 0 (day of surgery) up to 30 days post surgery
|
Day 0 (day of surgery) up to 30 days post surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0
Tidsramme: Baseline (pre-surgical)
|
Percentage of participants with NNISS score for increased preoperative risk of infection.
|
Baseline (pre-surgical)
|
|
ASEPSIS Classification in Participants With Serious SSI
Tidsramme: Up to 30 days post surgery
|
Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria, Stay in hospital prolonged over 14 days (ASEPSIS).
ASEPSIS classification is a numerical indication of wound healing progress: satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (20-30), moderate wound infection (30-40), and severe wound infection (over 40).
|
Up to 30 days post surgery
|
|
Classification of SSI Infection
Tidsramme: Day 0 (day of surgery) up to 30 days post surgery
|
Participants with organ-space or deep incisional SSI.
|
Day 0 (day of surgery) up to 30 days post surgery
|
|
Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)
Tidsramme: Day 0 (day of surgery) up to 30 days post surgery
|
Resolution of SSI ranged from eradication (infection cured) to persistence (infection continued).
|
Day 0 (day of surgery) up to 30 days post surgery
|
|
Number of Participants With Antimicrobial Resistance
Tidsramme: Day 0 (day of surgery) up to 30 days post surgery
|
Microbiological resistance reported for microorganisms that were found at a frequency greater (>) than 5 percent (%).
|
Day 0 (day of surgery) up to 30 days post surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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. februar 2009
Primær færdiggørelse (Faktiske)
1. november 2010
Studieafslutning (Faktiske)
1. november 2010
Datoer for studieregistrering
Først indsendt
19. maj 2009
Først indsendt, der opfyldte QC-kriterier
20. maj 2009
Først opslået (Skøn)
21. maj 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. maj 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. maj 2012
Sidst verificeret
1. maj 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B1811046
- 3074A1-4463 (Anden identifikator: Wyeth)
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 .