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

NCT00906074 | Completed Results

• 2 other identifiers: B18110463074A1-4463
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgical Wound Infection; Postoperative Wound Infection

Keywords

Surgical Wound Infection; Surgical Site Infection; Abdominal Surgery

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants With Pre-surgical Morbidities

  Morbidities (risk factors) included: neoplasm, tobacco use, body mass index (weight in kilograms divided by height in meters squared \[BMI kg/m2\]) greater than (\>) 30, diabetes mellitus (DM), immunosuppression/ corticosteroids, anemia (hemoglobin \[Hb\] less than (\>) 9 grams per deciliter \[gr/dL\]) or malnutrition (hypoalbuminemia).

  Baseline (Pre-surgical)

• Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis

  Baseline (Pre-surgical)

• Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery

  Day 0 (day of surgery)

• Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty

  Surgical infection risk class: Clean-contaminated: controlled entry in normally colonized body cavities/no unusual contamination/minimum fluid discharge/minimal sterile technique violation/re-surgery on clean surgical incision within 7 days/negative surgical exploration through intact skin. Contaminated: no acute inflammation/purulent discharge/significant fluid/material violation of sterile technique/penetrating trauma less than 4 hours old/graft in chronic skin wounds. Dirty: pus-abscess drainage/ preoperatively colonized body cavity perforated/penetrating trauma more than 4 hours old.

  Day 0 (day of surgery)

• Type of Surgeon

  Surgical speciality of physician who performed surgery.

  Day 0 (day of surgery)

• Percentage of Participants With Infection

  Microorganism infection by bacterial type.

  Day 0 (day of surgery) up to 30 days post surgery

• Percentage of Participants Who Showed Clinical Improvement of SSI

  Clinical improvement of SSI was defined as healed (signs and symptoms of initial infection resolved) or improved (initial signs and symptoms significantly diminished without the appearance of new signs).

  Day 0 (day of surgery) up to 30 days post surgery

• Percentage of Participants With Post-surgical Drainage

  Day 0 (day of surgery) up to 30 days post surgery

Secondary Outcomes (5)

• Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0

  Baseline (pre-surgical)

• ASEPSIS Classification in Participants With Serious SSI

  Up to 30 days post surgery

• Classification of SSI Infection

  Day 0 (day of surgery) up to 30 days post surgery

• Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)

  Day 0 (day of surgery) up to 30 days post surgery

• Number of Participants With Antimicrobial Resistance

  Day 0 (day of surgery) up to 30 days post surgery

Study Arms (2)

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.

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.

Procedure: Elective or emergency abdominal surgery

Interventions

Elective or emergency abdominal surgery PROCEDURE

Clinical record review.

Case

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Elective Surgical Procedures

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Limitations and Caveats

Adverse events and serious adverse events were not collected for this epidemiology study.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 21, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 15, 2012
• Results First Posted: April 11, 2012

Record last verified: 2012-05