Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected … (NCT00906074) | Clinical Trial Compass
CompletedNot Applicable
Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
180 participantsStarted 2009-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Pre-surgical Morbidities
Timeframe: Baseline (Pre-surgical)
2
Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis
Timeframe: Baseline (Pre-surgical)
3
Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery
Timeframe: Day 0 (day of surgery)
4
Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty
Timeframe: Day 0 (day of surgery)
5
Type of Surgeon
Timeframe: Day 0 (day of surgery)
6
Percentage of Participants With Infection
Timeframe: Day 0 (day of surgery) up to 30 days post surgery
7
Percentage of Participants Who Showed Clinical Improvement of SSI
Timeframe: Day 0 (day of surgery) up to 30 days post surgery