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

A Multicenter, Surgeon-Matched Case-Control Study of 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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound Infection; Postoperative Wound Infection
• Intervention / Treatment: Procedure: Elective or emergency abdominal surgery; Procedure: Elective or emergency abdominal surgery

Detailed Description

Case and Control study.

• Study Type: Observational
• Enrollment (Actual): 180

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; 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.; Procedure: Elective or emergency abdominal surgery; Clinical record review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0	Percentage of participants with NNISS score for increased preoperative risk of infection.	Baseline (pre-surgical)
ASEPSIS Classification in Participants With Serious SSI	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).	Up to 30 days post surgery
Classification of SSI Infection	Participants with organ-space or deep incisional SSI.	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)	Resolution of SSI ranged from eradication (infection cured) to persistence (infection continued).	Day 0 (day of surgery) up to 30 days post surgery
Number of Participants With Antimicrobial Resistance	Microbiological resistance reported for microorganisms that were found at a frequency greater (>) than 5 percent (%).	Day 0 (day of surgery) up to 30 days post surgery

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: May 19, 2009
• First Submitted That Met QC Criteria: May 20, 2009
• First Posted (Estimate): May 21, 2009

Study Record Updates

• Last Update Posted (Estimate): May 15, 2012
• Last Update Submitted That Met QC Criteria: May 9, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Abdominal Surgery; Surgical Wound Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: B1811046; 3074A1-4463 (Other Identifier: Wyeth)