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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Case and Control study.

Conditions

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Surgical Wound Infection Postoperative Wound Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Elective or emergency abdominal surgery

Intervention Type PROCEDURE

Clinical record review.

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.

Elective or emergency abdominal surgery

Intervention Type PROCEDURE

Clinical record review

Interventions

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Elective or emergency abdominal surgery

Clinical record review.

Intervention Type PROCEDURE

Elective or emergency abdominal surgery

Clinical record review

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No