Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery (EURIDICE)
|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 (%).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906074
|Study Director:||Pfizer CT.gov Call Center||Pfizer|