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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00906074
Acronym
EURIDICE
Enrollment
180
Registered
2009-05-21
Start date
2009-02-28
Completion date
2010-11-30
Last updated
2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Wound Infection, Surgical Wound Infection

Keywords

Surgical Wound Infection, Surgical Site Infection, Abdominal Surgery

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.

Interventions

PROCEDUREElective or emergency abdominal surgery

Clinical record review.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Post-surgical DrainageDay 0 (day of surgery) up to 30 days post surgery
Percentage of Participants Who Underwent Emergency Surgery or Scheduled SurgeryDay 0 (day of surgery)
Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or DirtyDay 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 SurgeonDay 0 (day of surgery)Surgical speciality of physician who performed surgery.
Percentage of Participants With InfectionDay 0 (day of surgery) up to 30 days post surgeryMicroorganism infection by bacterial type.
Percentage of Participants Who Showed Clinical Improvement of SSIDay 0 (day of surgery) up to 30 days post surgeryClinical 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 Pre-surgical MorbiditiesBaseline (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 ProphylaxisBaseline (Pre-surgical)

Secondary

MeasureTime frameDescription
Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0Baseline (pre-surgical)Percentage of participants with NNISS score for increased preoperative risk of infection.
ASEPSIS Classification in Participants With Serious SSIUp to 30 days post surgeryAdditional 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 InfectionDay 0 (day of surgery) up to 30 days post surgeryParticipants with organ-space or deep incisional SSI.
Number of Participants With Antimicrobial ResistanceDay 0 (day of surgery) up to 30 days post surgeryMicrobiological resistance reported for microorganisms that were found at a frequency greater (\>) than 5 percent (%).
Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)Day 0 (day of surgery) up to 30 days post surgeryResolution of SSI ranged from eradication (infection cured) to persistence (infection continued).

Participant flow

Pre-assignment details

289 participants were screened and 109 were excluded from analysis due to: no matching control, not meeting inclusion/exclusion criteria or did not meet matching criteria.

Participants by arm

ArmCount
Case
Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control \[CDC\] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
90
Control
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
90
Total180

Baseline characteristics

CharacteristicCaseControlTotal
Age Continuous62.49 years
STANDARD_DEVIATION 16.11
58.46 years
STANDARD_DEVIATION 20.4
60.47 years
STANDARD_DEVIATION 18.44
Sex: Female, Male
Female
27 Participants39 Participants66 Participants
Sex: Female, Male
Male
63 Participants51 Participants114 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis

Time frame: Baseline (Pre-surgical)

Population: Study Population

ArmMeasureValue (NUMBER)
CasePercentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis95.5 Percentage of participants
ControlPercentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis96.7 Percentage of participants
p-value: 1Chi-squared
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).

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

Population: Subset of study population with infection; N=number of participants with evaluable data

ArmMeasureGroupValue (NUMBER)
CasePercentage of Participants Who Showed Clinical Improvement of SSIhealed70.8 Percentage of participants
CasePercentage of Participants Who Showed Clinical Improvement of SSIImprovement27.0 Percentage of participants
Primary

Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery

Time frame: Day 0 (day of surgery)

Population: Study Population

ArmMeasureGroupValue (NUMBER)
CasePercentage of Participants Who Underwent Emergency Surgery or Scheduled SurgeryEmergency surgery32.2 Percentage of participants
CasePercentage of Participants Who Underwent Emergency Surgery or Scheduled SurgeryScheduled surgery67.8 Percentage of participants
ControlPercentage of Participants Who Underwent Emergency Surgery or Scheduled SurgeryEmergency surgery31.1 Percentage of participants
ControlPercentage of Participants Who Underwent Emergency Surgery or Scheduled SurgeryScheduled surgery68.9 Percentage of participants
p-value: 0.873Chi-squared
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.

Time frame: Day 0 (day of surgery)

Population: Study population

ArmMeasureGroupValue (NUMBER)
CasePercentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or DirtyClean-contaminated60.0 Percentage of participants
CasePercentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or DirtyContaminated30.0 Percentage of participants
CasePercentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or DirtyDirty10.0 Percentage of participants
ControlPercentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or DirtyClean-contaminated60.0 Percentage of participants
ControlPercentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or DirtyContaminated30.0 Percentage of participants
ControlPercentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or DirtyDirty10.0 Percentage of participants
Primary

Percentage of Participants With Infection

Microorganism infection by bacterial type.

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

Population: Subset of study population with infection; N=number of participants with evaluable data

ArmMeasureGroupValue (NUMBER)
CasePercentage of Participants With InfectionEscherichia coli (E. coli)55.8 Percentage of participants
CasePercentage of Participants With InfectionStaphylococcus aureus3.5 Percentage of participants
CasePercentage of Participants With InfectionExtended-spectrum β-lactamase producing E.coli3.5 Percentage of participants
CasePercentage of Participants With InfectionBacteroides fragilis group (gr.)14.0 Percentage of participants
CasePercentage of Participants With InfectionEnterococcus faecium12.8 Percentage of participants
CasePercentage of Participants With InfectionEnterococcus faecalis12.8 Percentage of participants
CasePercentage of Participants With InfectionPseudomonas aeruginosa8.1 Percentage of participants
CasePercentage of Participants With InfectionStaphylococcus epidermidis7.0 Percentage of participants
CasePercentage of Participants With InfectionCandida albicans5.8 Percentage of participants
CasePercentage of Participants With InfectionStaphylococcus species (spp)5.8 Percentage of participants
CasePercentage of Participants With InfectionMorganella morganni5.8 Percentage of participants
CasePercentage of Participants With InfectionKlebsiella oxytoca5.8 Percentage of participants
CasePercentage of Participants With InfectionKlebsiella pneumoniae4.7 Percentage of participants
CasePercentage of Participants With InfectionStreptococcus spp3.5 Percentage of participants
CasePercentage of Participants With InfectionStreptococcus other3.5 Percentage of participants
CasePercentage of Participants With InfectionStreptococcus anginosus3.5 Percentage of participants
CasePercentage of Participants With InfectionEnterobacter cloacae3.5 Percentage of participants
CasePercentage of Participants With InfectionStreptococcus viridians gr.2.3 Percentage of participants
CasePercentage of Participants With InfectionStreptococcus agalactiae2.3 Percentage of participants
CasePercentage of Participants With InfectionCoagulase-negative staphylococci2.3 Percentage of participants
CasePercentage of Participants With InfectionSerratia marcescens2.3 Percentage of participants
CasePercentage of Participants With InfectionPrevotella spp2.3 Percentage of participants
CasePercentage of Participants With InfectionEnterococcus spp2.3 Percentage of participants
CasePercentage of Participants With InfectionEnterococcus durans2.3 Percentage of participants
CasePercentage of Participants With InfectionBacteroides vulgates bacteroides (B) fragilis gr.2.3 Percentage of participants
CasePercentage of Participants With InfectionCandida glabrata1.2 Percentage of participants
CasePercentage of Participants With InfectionStenothropomonas maltophilia1.2 Percentage of participants
CasePercentage of Participants With InfectionMethicillin-resistant Staphylococcus aureus1.2 Percentage of participants
CasePercentage of Participants With InfectionSerratia spp1.2 Percentage of participants
CasePercentage of Participants With InfectionPseudomonas stutzeri1.2 Percentage of participants
CasePercentage of Participants With InfectionProteus vulgaris1.2 Percentage of participants
CasePercentage of Participants With InfectionLactobacillus spp1.2 Percentage of participants
CasePercentage of Participants With InfectionHaemophilus parainfluenzae1.2 Percentage of participants
CasePercentage of Participants With InfectionGemella spp1.2 Percentage of participants
CasePercentage of Participants With InfectionEubacterium gr.1.2 Percentage of participants
CasePercentage of Participants With InfectionEnterococcus avium1.2 Percentage of participants
CasePercentage of Participants With InfectionEnterobacter agglomerans1.2 Percentage of participants
CasePercentage of Participants With InfectionCitrobacter freundii1.2 Percentage of participants
CasePercentage of Participants With InfectionBacteroides no fragilis gr.1.2 Percentage of participants
CasePercentage of Participants With InfectionBacteroides thetaiotaomicrom B. fragilis gr.1.2 Percentage of participants
CasePercentage of Participants With InfectionBacteroides ovatus B. fragilis gr.1.2 Percentage of participants
CasePercentage of Participants With InfectionBacteroides distasonis B. fragilis gr.1.2 Percentage of participants
CasePercentage of Participants With InfectionNon-fermenting gram negative bacilli1.2 Percentage of participants
Primary

Percentage of Participants With Post-surgical Drainage

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

Population: Study Population

ArmMeasureValue (NUMBER)
CasePercentage of Participants With Post-surgical Drainage71.1 Percentage of participants
ControlPercentage of Participants With Post-surgical Drainage61.1 Percentage of participants
p-value: 0.156Chi-squared
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).

Time frame: Baseline (Pre-surgical)

Population: Study population: participants with or without SSI after surgery, treated in major hospitals with general surgical units located in Spain

ArmMeasureGroupValue (NUMBER)
CasePercentage of Participants With Pre-surgical MorbiditiesBMI kg/mˆ2>3023.3 percentage of participants
CasePercentage of Participants With Pre-surgical MorbiditiesImmunosuppression/corticosteroids7.8 percentage of participants
CasePercentage of Participants With Pre-surgical MorbiditiesTobacco use26.7 percentage of participants
CasePercentage of Participants With Pre-surgical MorbiditiesAnemia (Hb<9 gr/dL)7.8 percentage of participants
CasePercentage of Participants With Pre-surgical MorbiditiesNeoplasm47.8 percentage of participants
CasePercentage of Participants With Pre-surgical MorbiditiesMalnutrition (hypoalbuminemia)4.4 percentage of participants
CasePercentage of Participants With Pre-surgical MorbiditiesDiabetes mellitus17.8 percentage of participants
ControlPercentage of Participants With Pre-surgical MorbiditiesMalnutrition (hypoalbuminemia)2.2 percentage of participants
ControlPercentage of Participants With Pre-surgical MorbiditiesNeoplasm48.9 percentage of participants
ControlPercentage of Participants With Pre-surgical MorbiditiesBMI kg/mˆ2>3012.2 percentage of participants
ControlPercentage of Participants With Pre-surgical MorbiditiesDiabetes mellitus11.1 percentage of participants
ControlPercentage of Participants With Pre-surgical MorbiditiesImmunosuppression/corticosteroids7.8 percentage of participants
ControlPercentage of Participants With Pre-surgical MorbiditiesAnemia (Hb<9 gr/dL)2.2 percentage of participants
ControlPercentage of Participants With Pre-surgical MorbiditiesTobacco use23.3 percentage of participants
Comparison: Neoplasmp-value: 0.881Chi-squared
Comparison: Tobacco usep-value: 0.517Chi-squared
Comparison: BMI(kg/mˆ2)\>30p-value: 0.053Chi-squared
Comparison: Diabetes mellitusp-value: 0.289Chi-squared
Comparison: Immunosuppression/Corticosteroidsp-value: 1Chi-squared
Comparison: Anemia (Hb\<9gr/dL)p-value: 0.169Chi-squared
Comparison: Malnutrition (hypoalbuminemia)p-value: 0.637Chi-squared
Primary

Type of Surgeon

Surgical speciality of physician who performed surgery.

Time frame: Day 0 (day of surgery)

Population: No data collected

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).

Time frame: Up to 30 days post surgery

Population: Subset of study population with infection

ArmMeasureGroupValue (NUMBER)
CaseASEPSIS Classification in Participants With Serious SSISatisfactory healing1 participants
CaseASEPSIS Classification in Participants With Serious SSIDisturbance of healing12 participants
CaseASEPSIS Classification in Participants With Serious SSIMinor wound infection58 participants
CaseASEPSIS Classification in Participants With Serious SSIModerate wound infection15 participants
CaseASEPSIS Classification in Participants With Serious SSISevere wound infection4 participants
Secondary

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

Population: Subset of study population with infection; N=number of participants with evaluable data

ArmMeasureGroupValue (NUMBER)
CaseClassification of SSI InfectionOrgan-space infection60 participants
CaseClassification of SSI InfectionDeep incisional infection29 participants
Secondary

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

Population: Subset of study population with infection; N=number of participants with evaluable data

ArmMeasureGroupValue (NUMBER)
CaseNumber of Participants With Antimicrobial ResistanceMorganella morganni (Cef-3)2 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceMorganella morganni (Carb)0 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceE. coli-cephalosporins 3rd generation (Cef-3)1 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceEscherichia coli-carbapenems (Carb)0 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceEscherichia coli-fluoroquinolones (FQ)7 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceBacteroides fragilis gr. (Cef-3)0 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceBacteroides fragilis gr. (Carb)1 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceBacteroides fragilis gr. (FQ)4 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceEnterococcus faecium (Cef-3)0 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceEnterococcus faecium (Carb)1 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceEnterococcus faecium (FQ)0 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceEnterococcus faecalis (FQ)2 Number of participants
CaseNumber of Participants With Antimicrobial ResistancePseudomonas aeruginosa (Cef-3)1 Number of participants
CaseNumber of Participants With Antimicrobial ResistancePseudomonas aeruginosa (Carb)1 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceMorganella morganni (FQ)0 Number of participants
CaseNumber of Participants With Antimicrobial ResistancePseudomonas aeruginosa (FQ)1 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceStaphylococus epidermis (FQ)4 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceStaphylococus spp (FQ)4 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceEnterococcus faecium (enterococcus vancomycin[EV])0 Number of participants
CaseNumber of Participants With Antimicrobial ResistanceEnterococcus faecalis (EV)0 Number of participants
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).

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

Population: Subset of study population with infection; N=number of participants with evaluable data

ArmMeasureGroupValue (NUMBER)
CasePercentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)Erradication29.2 Percentage of participants
CasePercentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)Presumed erradication57.3 Percentage of participants
CasePercentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)Persistance4.5 Percentage of participants
CasePercentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)Unknown9.0 Percentage of participants
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.

Time frame: Baseline (pre-surgical)

Population: Study population

ArmMeasureGroupValue (NUMBER)
CasePercentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >01.5 % increased risk23.3 Percentage of participants
CasePercentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >02.9% increased risk50.0 Percentage of participants
CasePercentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >06.8% increased risk23.3 Percentage of participants
CasePercentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >013.0% increased risk3.3 Percentage of participants
ControlPercentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >013.0% increased risk2.2 Percentage of participants
ControlPercentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >01.5 % increased risk26.7 Percentage of participants
ControlPercentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >06.8% increased risk14.4 Percentage of participants
ControlPercentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >02.9% increased risk56.7 Percentage of participants
p-value: 0.444Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026