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

Last updated on November 13, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Surgical Wound Infection, Postoperative Wound Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Age under 18 years.

- American Society of Anesthesiologist (ASA) score of 5 or above.

- Surgical implant in place.

- Clean or clean-contaminated surgical procedures.

NCT00906074
Pfizer
Completed
Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery

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Descriptive Information
Brief TitleStudy Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
Official TitleA Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
Brief SummaryThis 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 DescriptionCase and Control study.
Study TypeObservational
Study DesignObservational Model: Case Control
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with or without surgical site infections (SSI) after surgery, treated in major hospitals with general surgical units selected from all over Spain
Condition
  • Surgical Wound Infection
  • Postoperative Wound Infection
Intervention
  • Procedure: Elective or emergency abdominal surgery
    Clinical record review.
  • Procedure: Elective or emergency abdominal surgery
    Clinical record review
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Procedure: Elective or emergency abdominal surgery
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: April 24, 2012)
180
Original Estimated Enrollment
 (submitted: May 20, 2009)
1000
Actual Study Completion DateNovember 2010
Actual Primary Completion DateNovember 2010   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location CountriesSpain
 
Administrative Information
NCT NumberNCT00906074
Other Study ID NumbersB1811046
3074A1-4463 ( Other Identifier: Wyeth )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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