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

NCT00906074

Last updated date
Contact
1-800-718-1021

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

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Surgical Wound Infection, Postoperative Wound InfectionStudy Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
NCT00906074
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
Official Title A Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
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 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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
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 Status Completed
Actual Enrollment
 (submitted: April 24, 2012)
180
Original Estimated Enrollment
 (submitted: May 20, 2009)
1000
Actual Study Completion Date November 2010
Actual Primary Completion Date November 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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Spain
 
Administrative Information
NCT Number NCT00906074
Other Study ID Numbers B1811046
3074A1-4463 ( Other Identifier: Wyeth )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2012