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

Completed

• Conditions: Surgical Wound Infection; Postoperative Wound Infection
• Interventions: Procedure: Elective or emergency abdominal surgery

• Registration Number: NCT00906074
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Case and Control study.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2012-03-09
• Results First Submitted QC: 2012-03-09
• Results First Posted: 2012-04-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Elective or emergency abdominal surgery	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.
Case	Elective or emergency abdominal surgery	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Pre-surgical Morbidities	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	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	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	Day 0 (day of surgery)	Surgical speciality of physician who performed surgery.
Percentage of Participants With Infection	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	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	Day 0 (day of surgery) up to 30 days post surgery

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0	Baseline (pre-surgical)	Percentage of participants with NNISS score for increased preoperative risk of infection.
ASEPSIS Classification in Participants With Serious SSI	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	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)	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	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 (%).