Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Surgical Wound Infection

Postoperative Wound Infection

Eligibility:

All Genders

18+ years

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...

Detailed Description

Case and Control study.

Eligibility Criteria

Inclusion

  • 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

  • Age under 18 years.
  • American Society of Anesthesiologist (ASA) score of 5 or above.
  • Surgical implant in place.
  • Clean or clean-contaminated surgical procedures.

Key Trial Info

Start Date :

February 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 1 2010

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT00906074

Start Date

February 1 2009

End Date

November 1 2010

Last Update

May 15 2012

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