Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery (EURIDICE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00906074
First received: May 19, 2009
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Surgical Wound Infection
Postoperative Wound Infection
Procedure: Elective or emergency abdominal surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Pre-surgical Morbidities [ Time Frame: Baseline (Pre-surgical) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery [ Time Frame: Day 0 (day of surgery) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty [ Time Frame: Day 0 (day of surgery) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Microbiological resistance reported for microorganisms that were found at a frequency greater (>) than 5 percent (%).


Enrollment: 180
Study Start Date: February 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Procedure: Elective or emergency abdominal surgery
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.
Procedure: Elective or emergency abdominal surgery
Clinical record review

Detailed Description:

Case and Control study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with or without surgical site infections (SSI) after surgery, treated in major hospitals with general surgical units selected from all over Spain

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906074

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00906074     History of Changes
Other Study ID Numbers: B1811046, 3074A1-4463
Study First Received: May 19, 2009
Results First Received: March 9, 2012
Last Updated: May 9, 2012
Health Authority: Spain: Ethics Committee

Keywords provided by Pfizer:
Surgical Wound Infection
Surgical Site Infection
Abdominal Surgery

Additional relevant MeSH terms:
Communicable Diseases
Infection
Surgical Wound Infection
Wound Infection
Pathologic Processes
Postoperative Complications
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014