Trial Outcomes & Findings for Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery (NCT NCT00906074)
NCT ID: NCT00906074
Last Updated: 2012-05-15
Results Overview
Microorganism infection by bacterial type.
Recruitment status
COMPLETED
Target enrollment
180 participants
Primary outcome timeframe
Day 0 (day of surgery) up to 30 days post surgery
Results posted on
2012-05-15
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Control
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
|
Overall Study
COMPLETED
|
90
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
Baseline characteristics by cohort
| Measure |
Case
n=90 Participants
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.
|
Control
n=90 Participants
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62.49 years
STANDARD_DEVIATION 16.11 • n=5 Participants
|
58.46 years
STANDARD_DEVIATION 20.40 • n=7 Participants
|
60.47 years
STANDARD_DEVIATION 18.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-surgical)Population: Study population: participants with or without SSI after surgery, treated in major hospitals with general surgical units located in Spain
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).
Outcome measures
| Measure |
Case
n=90 Participants
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.
|
Control
n=90 Participants
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Percentage of Participants With Pre-surgical Morbidities
Neoplasm
|
47.8 percentage of participants
|
48.9 percentage of participants
|
|
Percentage of Participants With Pre-surgical Morbidities
Tobacco use
|
26.7 percentage of participants
|
23.3 percentage of participants
|
|
Percentage of Participants With Pre-surgical Morbidities
BMI kg/mˆ2>30
|
23.3 percentage of participants
|
12.2 percentage of participants
|
|
Percentage of Participants With Pre-surgical Morbidities
Diabetes mellitus
|
17.8 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Pre-surgical Morbidities
Immunosuppression/corticosteroids
|
7.8 percentage of participants
|
7.8 percentage of participants
|
|
Percentage of Participants With Pre-surgical Morbidities
Anemia (Hb<9 gr/dL)
|
7.8 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With Pre-surgical Morbidities
Malnutrition (hypoalbuminemia)
|
4.4 percentage of participants
|
2.2 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (Pre-surgical)Population: Study Population
Outcome measures
| Measure |
Case
n=90 Participants
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.
|
Control
n=90 Participants
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis
|
95.5 Percentage of participants
|
96.7 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (day of surgery)Population: Study Population
Outcome measures
| Measure |
Case
n=90 Participants
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.
|
Control
n=90 Participants
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery
Emergency surgery
|
32.2 Percentage of participants
|
31.1 Percentage of participants
|
|
Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery
Scheduled surgery
|
67.8 Percentage of participants
|
68.9 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (day of surgery)Population: Study population
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.
Outcome measures
| Measure |
Case
n=90 Participants
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.
|
Control
n=90 Participants
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty
Clean-contaminated
|
60.0 Percentage of participants
|
60.0 Percentage of participants
|
|
Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty
Contaminated
|
30.0 Percentage of participants
|
30.0 Percentage of participants
|
|
Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty
Dirty
|
10.0 Percentage of participants
|
10.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 (day of surgery)Population: No data collected
Surgical speciality of physician who performed surgery.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 0 (day of surgery) up to 30 days post surgeryPopulation: Subset of study population with infection; N=number of participants with evaluable data
Microorganism infection by bacterial type.
Outcome measures
| Measure |
Case
n=86 Participants
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.
|
Control
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Percentage of Participants With Infection
Bacteroides no fragilis gr.
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Bacteroides thetaiotaomicrom B. fragilis gr.
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Escherichia coli (E. coli)
|
55.8 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Bacteroides fragilis group (gr.)
|
14.0 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Enterococcus faecium
|
12.8 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Enterococcus faecalis
|
12.8 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Pseudomonas aeruginosa
|
8.1 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Staphylococcus epidermidis
|
7.0 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Candida albicans
|
5.8 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Staphylococcus species (spp)
|
5.8 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Morganella morganni
|
5.8 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Klebsiella oxytoca
|
5.8 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Klebsiella pneumoniae
|
4.7 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Streptococcus spp
|
3.5 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Streptococcus other
|
3.5 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Streptococcus anginosus
|
3.5 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Staphylococcus aureus
|
3.5 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Extended-spectrum β-lactamase producing E.coli
|
3.5 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Enterobacter cloacae
|
3.5 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Streptococcus viridians gr.
|
2.3 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Streptococcus agalactiae
|
2.3 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Coagulase-negative staphylococci
|
2.3 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Serratia marcescens
|
2.3 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Prevotella spp
|
2.3 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Enterococcus spp
|
2.3 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Enterococcus durans
|
2.3 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Bacteroides vulgates bacteroides (B) fragilis gr.
|
2.3 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Candida glabrata
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Stenothropomonas maltophilia
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Methicillin-resistant Staphylococcus aureus
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Serratia spp
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Pseudomonas stutzeri
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Proteus vulgaris
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Lactobacillus spp
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Haemophilus parainfluenzae
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Gemella spp
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Eubacterium gr.
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Enterococcus avium
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Enterobacter agglomerans
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Citrobacter freundii
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Bacteroides ovatus B. fragilis gr.
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Bacteroides distasonis B. fragilis gr.
|
1.2 Percentage of participants
|
—
|
|
Percentage of Participants With Infection
Non-fermenting gram negative bacilli
|
1.2 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 (day of surgery) up to 30 days post surgeryPopulation: Subset of study population with infection; N=number of participants with evaluable data
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).
Outcome measures
| Measure |
Case
n=89 Participants
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.
|
Control
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Percentage of Participants Who Showed Clinical Improvement of SSI
healed
|
70.8 Percentage of participants
|
—
|
|
Percentage of Participants Who Showed Clinical Improvement of SSI
Improvement
|
27.0 Percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Day 0 (day of surgery) up to 30 days post surgeryPopulation: Study Population
Outcome measures
| Measure |
Case
n=90 Participants
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.
|
Control
n=90 Participants
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Percentage of Participants With Post-surgical Drainage
|
71.1 Percentage of participants
|
61.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (pre-surgical)Population: Study population
Percentage of participants with NNISS score for increased preoperative risk of infection.
Outcome measures
| Measure |
Case
n=90 Participants
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.
|
Control
n=90 Participants
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0
1.5 % increased risk
|
23.3 Percentage of participants
|
26.7 Percentage of participants
|
|
Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0
2.9% increased risk
|
50.0 Percentage of participants
|
56.7 Percentage of participants
|
|
Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0
6.8% increased risk
|
23.3 Percentage of participants
|
14.4 Percentage of participants
|
|
Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0
13.0% increased risk
|
3.3 Percentage of participants
|
2.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 30 days post surgeryPopulation: Subset of study population with infection
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).
Outcome measures
| Measure |
Case
n=90 Participants
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.
|
Control
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
ASEPSIS Classification in Participants With Serious SSI
Satisfactory healing
|
1 participants
|
—
|
|
ASEPSIS Classification in Participants With Serious SSI
Disturbance of healing
|
12 participants
|
—
|
|
ASEPSIS Classification in Participants With Serious SSI
Minor wound infection
|
58 participants
|
—
|
|
ASEPSIS Classification in Participants With Serious SSI
Moderate wound infection
|
15 participants
|
—
|
|
ASEPSIS Classification in Participants With Serious SSI
Severe wound infection
|
4 participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 (day of surgery) up to 30 days post surgeryPopulation: Subset of study population with infection; N=number of participants with evaluable data
Participants with organ-space or deep incisional SSI.
Outcome measures
| Measure |
Case
n=89 Participants
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.
|
Control
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Classification of SSI Infection
Organ-space infection
|
60 participants
|
—
|
|
Classification of SSI Infection
Deep incisional infection
|
29 participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 (day of surgery) up to 30 days post surgeryPopulation: Subset of study population with infection; N=number of participants with evaluable data
Resolution of SSI ranged from eradication (infection cured) to persistence (infection continued).
Outcome measures
| Measure |
Case
n=89 Participants
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.
|
Control
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)
Erradication
|
29.2 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)
Presumed erradication
|
57.3 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)
Persistance
|
4.5 Percentage of participants
|
—
|
|
Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)
Unknown
|
9.0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Day 0 (day of surgery) up to 30 days post surgeryPopulation: Subset of study population with infection; N=number of participants with evaluable data
Microbiological resistance reported for microorganisms that were found at a frequency greater (\>) than 5 percent (%).
Outcome measures
| Measure |
Case
n=88 Participants
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.
|
Control
Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
|
|---|---|---|
|
Number of Participants With Antimicrobial Resistance
E. coli-cephalosporins 3rd generation (Cef-3)
|
1 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Escherichia coli-carbapenems (Carb)
|
0 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Escherichia coli-fluoroquinolones (FQ)
|
7 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Bacteroides fragilis gr. (Cef-3)
|
0 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Bacteroides fragilis gr. (Carb)
|
1 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Bacteroides fragilis gr. (FQ)
|
4 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Enterococcus faecium (Cef-3)
|
0 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Enterococcus faecium (Carb)
|
1 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Enterococcus faecium (FQ)
|
0 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Enterococcus faecalis (FQ)
|
2 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Pseudomonas aeruginosa (Cef-3)
|
1 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Pseudomonas aeruginosa (Carb)
|
1 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Pseudomonas aeruginosa (FQ)
|
1 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Staphylococus epidermis (FQ)
|
4 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Staphylococus spp (FQ)
|
4 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Morganella morganni (Cef-3)
|
2 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Morganella morganni (Carb)
|
0 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Morganella morganni (FQ)
|
0 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Enterococcus faecium (enterococcus vancomycin[EV])
|
0 Number of participants
|
—
|
|
Number of Participants With Antimicrobial Resistance
Enterococcus faecalis (EV)
|
0 Number of participants
|
—
|
Adverse Events
Case
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER