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

Surgical Wound Infection Clinical Trial

— EURIDICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906074
• Other study ID #: B1811046
• Secondary ID: 3074A1-4463
• Status: Completed
• Phase: N/A
• First received: May 19, 2009
• Last updated: May 9, 2012
• Start date: February 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

Case and Control study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Postoperative Wound Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Procedure:
• Elective or emergency abdominal surgery
Clinical record review.
• Elective or emergency abdominal surgery
Clinical record review

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis		Baseline (Pre-surgical)	No
Primary	Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery		Day 0 (day of surgery)	No
Primary	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)	No
Primary	Type of Surgeon	Surgical speciality of physician who performed surgery.	Day 0 (day of surgery)	No
Primary	Percentage of Participants With Infection	Microorganism infection by bacterial type.	Day 0 (day of surgery) up to 30 days post surgery	No
Primary	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	No
Primary	Percentage of Participants With Post-surgical Drainage		Day 0 (day of surgery) up to 30 days post surgery	No
Secondary	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)	No
Secondary	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	No
Secondary	Classification of SSI Infection	Participants with organ-space or deep incisional SSI.	Day 0 (day of surgery) up to 30 days post surgery	No
Secondary	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	No
Secondary	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	No

External Links

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