EURIDICE
A Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
Sponsor study identifier
Secondary identifiers
OTHER · Wyeth
observational
180
0 countries
N/A
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
May 19, 2009
Actual (reported)May 21, 2009
Actual (reported)November 2010
Actual (reported)November 2010
Actual (reported)April 11, 2012
Actual (reported)Percentage of Participants With Pre-surgical Morbidities
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
Baseline (Pre-surgical)
Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery
Day 0 (day of surgery)
Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty
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.
Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0
Baseline (pre-surgical)
ASEPSIS Classification in Participants With Serious SSI
Up to 30 days post surgery
Classification of SSI Infection
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)
Day 0 (day of surgery) up to 30 days post surgery
Number of Participants With Antimicrobial Resistance
Day 0 (day of surgery) up to 30 days post surgery
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.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with or without surgical site infections (SSI) after surgery, treated in major hospitals with general surgical units selected from all over Spain
Adverse events and serious adverse events were not collected for this epidemiology study.
Pfizer CT.gov Call Center
Pfizer
180 participants (actual enrollment reported by the registry).
First Submitted
May 19, 2009
First Posted
May 21, 2009
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Eliminate Risk of Cardiac Surgical Site Events
Day 0 (day of surgery)
Type of Surgeon
Surgical speciality of physician who performed surgery.
Day 0 (day of surgery)
Percentage of Participants With Infection
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
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
Day 0 (day of surgery) up to 30 days post surgery
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Primary Completion
November 2010
Actual (reported)Study Completion
November 2010
Actual (reported)Last Updated
May 15, 2012
Results First Posted
April 11, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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