Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery (EURIDICE)
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|ClinicalTrials.gov Identifier: NCT00906074|
Recruitment Status : Completed
First Posted : May 21, 2009
Results First Posted : April 11, 2012
Last Update Posted : May 15, 2012
|Condition or disease||Intervention/treatment|
|Surgical Wound Infection Postoperative Wound Infection||Procedure: Elective or emergency abdominal surgery|
|Study Type :||Observational|
|Actual Enrollment :||180 participants|
|Observational Model:||Case Control|
|Official Title:||A Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
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.
Procedure: Elective or emergency abdominal surgery
Clinical record review.
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.
Procedure: Elective or emergency abdominal surgery
Clinical record review
- Percentage of Participants With Pre-surgical Morbidities [ Time Frame: 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).
- Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis [ Time Frame: Baseline (Pre-surgical) ]
- Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery [ Time Frame: Day 0 (day of surgery) ]
- Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty [ Time Frame: 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.
- Type of Surgeon [ Time Frame: Day 0 (day of surgery) ]Surgical speciality of physician who performed surgery.
- Percentage of Participants With Infection [ Time Frame: Day 0 (day of surgery) up to 30 days post surgery ]Microorganism infection by bacterial type.
- Percentage of Participants Who Showed Clinical Improvement of SSI [ Time Frame: 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).
- Percentage of Participants With Post-surgical Drainage [ Time Frame: Day 0 (day of surgery) up to 30 days post surgery ]
- Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0 [ Time Frame: Baseline (pre-surgical) ]Percentage of participants with NNISS score for increased preoperative risk of infection.
- ASEPSIS Classification in Participants With Serious SSI [ Time Frame: 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).
- Classification of SSI Infection [ Time Frame: Day 0 (day of surgery) up to 30 days post surgery ]Participants with organ-space or deep incisional SSI.
- Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics) [ Time Frame: Day 0 (day of surgery) up to 30 days post surgery ]Resolution of SSI ranged from eradication (infection cured) to persistence (infection continued).
- Number of Participants With Antimicrobial Resistance [ Time Frame: 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 (%).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906074
|Study Director:||Pfizer CT.gov Call Center||Pfizer|