N/A
N=180
Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
Surgical Wound Infection · Postoperative Wound Infection
Bottom Line
View on ClinicalTrials.gov: NCT00906074 ↗Enrolled (actual)
180
Serious AEs
—
Results posted
Apr 2012
Primary outcome: Primary: Percentage of Participants With Pre-surgical Morbidities — 47.8; 48.9; 26.7; 23.3 percentage of participants — p=0.881
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Elective or emergency abdominal surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Pre-surgical Morbidities |
47.8; 48.9; 26.7; 23.3; 23.3; 12.2 | 0.881 |
| PRIMARY Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis |
95.5; 96.7 | 1.000 |
| PRIMARY Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery |
32.2; 31.1; 67.8; 68.9 | 0.873 |
| PRIMARY Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty |
60.0; 60.0; 30.0; 30.0; 10.0; 10.0 | — |
| PRIMARY Type of Surgeon |
— | — |
| PRIMARY Percentage of Participants With Infection |
55.8; 14.0; 12.8; 12.8; 8.1; 7.0 | — |
| PRIMARY Percentage of Participants Who Showed Clinical Improvement of SSI |
70.8; 27.0 | — |
| PRIMARY Percentage of Participants With Post-surgical Drainage |
71.1; 61.1 | 0.156 |
| SECONDARY Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0 |
23.3; 26.7; 50.0; 56.7; 23.3; 14.4 | 0.444 |
| SECONDARY ASEPSIS Classification in Participants With Serious SSI |
1; 12; 58; 15; 4 | — |
| SECONDARY Classification of SSI Infection |
60; 29 | — |
| SECONDARY Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics) |
29.2; 57.3; 4.5; 9.0 | — |
| SECONDARY Number of Participants With Antimicrobial Resistance |
1; 0; 7; 0; 1; 4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00906074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.