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Completed

NCT Number: NCT00906074

Study Evaluating 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.

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Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Case and Control study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Elective or emergency abdominal surgery

Procedure

Clinical record review.

Primary outcomes

  1. 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).

  2. Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis

    Time frame: Baseline (Pre-surgical)

  3. Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery

    Time frame: Day 0 (day of surgery)

  4. 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.

  5. Type of Surgeon

    Time frame: Day 0 (day of surgery)

    Surgical speciality of physician who performed surgery.

  6. Percentage of Participants With Infection

    Time frame: Day 0 (day of surgery) up to 30 days post surgery

    Microorganism infection by bacterial type.

  7. 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).

  8. Percentage of Participants With Post-surgical Drainage

    Time frame: Day 0 (day of surgery) up to 30 days post surgery

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. 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 (%).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery

Acronym: EURIDICE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 21, 2009
Registry last updated
May 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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