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

Last updated on December 6, 2018

FOR MORE INFORMATION
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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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
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.
Case and Control study.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with or without surgical site infections (SSI) after surgery, treated in major hospitals with general surgical units selected from all over Spain
  • Surgical Wound Infection
  • Postoperative Wound Infection
  • Procedure: Elective or emergency abdominal surgery
    Clinical record review.
  • Procedure: Elective or emergency abdominal surgery
    Clinical record review
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
November 2010
November 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Spain
 
NCT00906074
B1811046
3074A1-4463 ( Other Identifier: Wyeth )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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