Clinical trial NCT00906074: Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
Official title: A Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Wound Infection
Postoperative Wound Infection
Keywords: Surgical Wound Infection
Surgical Site Infection
Abdominal Surgery
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Pre-surgical Morbidities
timeFrame: Baseline (Pre-surgical)
measure: Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis
timeFrame: Baseline (Pre-surgical)
measure: Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery
timeFrame: Day 0 (day of surgery)
measure: Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty
timeFrame: Day 0 (day of surgery)
measure: Type of Surgeon
timeFrame: Day 0 (day of surgery)
measure: Percentage of Participants With Infection
timeFrame: Day 0 (day of surgery) up to 30 days post surgery
measure: Percentage of Participants Who Showed Clinical Improvement of SSI
timeFrame: Day 0 (day of surgery) up to 30 days post surgery
measure: Percentage of Participants With Post-surgical Drainage
timeFrame: Day 0 (day of surgery) up to 30 days post surgery
Secondary outcomes:
measure: Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0
timeFrame: Baseline (pre-surgical)
measure: ASEPSIS Classification in Participants With Serious SSI
timeFrame: Up to 30 days post surgery
measure: Classification of SSI Infection
timeFrame: Day 0 (day of surgery) up to 30 days post surgery
measure: Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)
timeFrame: Day 0 (day of surgery) up to 30 days post surgery
measure: Number of Participants With Antimicrobial Resistance
timeFrame: Day 0 (day of surgery) up to 30 days post surgery
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: