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

Pfizer180 enrolled

Overview

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.

Case and Control study.

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Surgical Wound Infection Postoperative Wound Infection

Interventions

Elective or emergency abdominal surgeryPROCEDURE

Clinical record review.

Elective or emergency abdominal surgeryPROCEDURE

Clinical record review

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Baseline (Pre-surgical)

Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis

Time frame: Baseline (Pre-surgical)

Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery

Time frame: 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.

Time frame: Day 0 (day of surgery)

Type of Surgeon

Surgical speciality of physician who performed surgery.

Time frame: Day 0 (day of surgery)

Percentage of Participants With Infection

Microorganism infection by bacterial type.

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

Percentage of Participants Who Showed Clinical Improvement of SSI

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 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).

Time frame: Up to 30 days post surgery

Classification of SSI Infection

Participants with organ-space or deep incisional SSI.

Time frame: 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).

Time frame: 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 (%).

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