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

Pfizer

Status: Completed

Conditions: Surgical Wound Infection; Postoperative Wound Infection

Treatments: Procedure: Elective or emergency abdominal surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT00906074

3074A1-4463 (Other Identifier)

B1811046

Details and patient eligibility

About

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.

Full description

Case and Control study.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

180 participants in 2 patient groups

Case

Description:

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.

Treatment:

Procedure: Elective or emergency abdominal surgery

Procedure: Elective or emergency abdominal surgery

Control

Description:

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.

Treatment:

Procedure: Elective or emergency abdominal surgery

Procedure: Elective or emergency abdominal surgery