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

Study Overview
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Brief Summary
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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
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Case and Control study.

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

Conditions
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Surgical Wound Infection, Postoperative Wound Infection

Intervention / Treatment
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* Procedure: Elective or emergency abdominal surgery
* Procedure: Elective or emergency abdominal surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>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<br>* Clinical record review.<br>|
| Control<br>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<br>* Clinical record review<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Wound Infection, Surgical Site Infection, Abdominal Surgery