Surgical Wound InfectionEURIDICENCT00906074
Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
An observational study of Surgical Wound Infection and Postoperative Wound Infection, run by Pfizer.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection, Postoperative Wound Infection
- What is being tested?
- Elective or emergency abdominal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Nov 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Age under 18 years.
- American Society of Anesthesiologist (ASA) score of 5 or above.
- Surgical implant in place.
- Clean or clean-contaminated surgical procedures.
About this study
Official title: A Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
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.
Read the detailed description
Case and Control study.
- Being tested
- Elective or emergency abdominal surgery
- Keywords
- Surgical Wound Infection, Surgical Site Infection, Abdominal Surgery
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective or emergency abdominal surgeryProcedure or surgery
Clinical record review.
Elective or emergency abdominal surgeryProcedure or surgery
Clinical record review
| Study group | Role | What they receive |
|---|---|---|
| Case | 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. Receives: Procedure: Elective or emergency abdominal surgery | |
| Control | 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. Receives: Procedure: Elective or emergency abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (Pre-surgical)
Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis
Measured: Baseline (Pre-surgical)
Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery
Measured: 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.
Measured: Day 0 (day of surgery)
Type of Surgeon
Surgical speciality of physician who performed surgery.
Measured: Day 0 (day of surgery)
Percentage of Participants With Infection
Microorganism infection by bacterial type.
Measured: 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).
Measured: Day 0 (day of surgery) up to 30 days post surgery
Percentage of Participants With Post-surgical Drainage
Measured: Day 0 (day of surgery) up to 30 days post surgery
Secondary outcomes (5)
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.
Measured: 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).
Measured: Up to 30 days post surgery
Classification of SSI Infection
Participants with organ-space or deep incisional SSI.
Measured: 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).
Measured: 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 (%).
Measured: Day 0 (day of surgery) up to 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906074
- Sponsor's protocol ID
- B1811046
- Other IDs
- 3074A1-4463
- Acronym
- EURIDICE
- Status last verified
- May 2012
- First submitted
- 19 May 2009
- Last updated
- 15 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00906074
- Acronym / sponsor ID
- EURIDICE / B1811046
- Keywords
- Surgical Wound Infection, Surgical Site Infection, Abdominal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Posted 11 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Procedure: Elective or emergency abdominal surgeryCases 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. |
| Control | – | Procedure: Elective or emergency abdominal surgerySurgeon-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Age under 18 years.
- American Society of Anesthesiologist (ASA) score of 5 or above.
- Surgical implant in place.
- Clean or clean-contaminated surgical procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective or emergency abdominal surgeryClinical record review. | Procedure or surgery | Case |
| Elective or emergency abdominal surgeryClinical record review | Procedure or surgery | Control |
Primary outcome
Percentage of Participants With Pre-surgical Morbidities
Time frame: Baseline (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 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
Time frame: Day 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 Surgeon
Time frame: Day 0 (day of surgery)
Surgical speciality of physician who performed surgery.
Percentage of Participants With Infection
Time frame: Day 0 (day of surgery) up to 30 days post surgery
Microorganism infection by bacterial type.
Percentage of Participants Who Showed Clinical Improvement of SSI
Time frame: Day 0 (day of surgery) up to 30 days post surgery
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).
Percentage of Participants With Post-surgical Drainage
Time frame: Day 0 (day of surgery) up to 30 days post surgery
5 secondary outcomes
Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0
Time frame: Baseline (pre-surgical)
ASEPSIS Classification in Participants With Serious SSI
Time frame: Up to 30 days post surgery
Classification of SSI Infection
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)
Time frame: Day 0 (day of surgery) up to 30 days post surgery
Number of Participants With Antimicrobial Resistance
Time frame: Day 0 (day of surgery) up to 30 days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound Infection and Postoperative Wound Infection, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Pre-surgical Morbidities (time frame: Baseline (Pre-surgical)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.