- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05355376
Colorectal Surgical Site Infection
April 29, 2022 updated by: Aldara Filipa Peixoto Faria, Centro Hospitalar Universitário Lisboa Norte
Colorectal Surgical Site Infection: a Cohort Study About How Can we Decrease it
Surgical site infection (SSI) is one of the most common postoperative complications in surgery, with high morbidity.
In the tertiary-center that the investigators evaluated they had a significant rate of surgical site infection.
Because of that the investigators created a care bundle of measures in order to improve the outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prospectively the investigators implemented a care bundle of measures with retrospective analysis, to decrease SSI . The superficial, deep and organ/space infections were evaluated and compared before and after care bundle implementation.
Between january 1, 2016 and December 31, 2020, 1139 patient records relating to surgical incisions were submitted for analysis.
Study Type
Observational
Enrollment (Actual)
1139
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients submitted to eletive colorectal surgery, by laparotomy, during a period of 5 years, in our colorectal department
Description
Inclusion Criteria:
- Patients submitted to elective colorectal surgery between 2016, january 1 and 2020, december 31
- Age > 18 years
- At least 30 days of follow-up
Exclusion Criteria:
- Patients submitted to urgent colorectal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of surgical site infections
Time Frame: 5 years
|
Evaluate the variation of surgical site infections during a period of 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
April 11, 2022
First Submitted That Met QC Criteria
April 26, 2022
First Posted (Actual)
May 2, 2022
Study Record Updates
Last Update Posted (Actual)
May 5, 2022
Last Update Submitted That Met QC Criteria
April 29, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgical Site Infection
-
Gundersen Lutheran Medical FoundationGundersen Lutheran Health SystemCompletedSurgical Site Infection | Superficial Surgical Site Infection | Deep Surgical Site Infection | Organ/Space Surgical Site InfectionUnited States
-
King Faisal Specialist Hospital & Research CenterEnrolling by invitationSurgical Site Infections | Surgical Site Infection After Major SurgerySaudi Arabia
-
MinaPharm PharmaceuticalsRecruitingSurgical Site InfectionsEgypt
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Karolinska University HospitalStockholm South General HospitalRecruitingPostoperative Surgical Site InfectionSweden
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Washington University School of MedicineCompleted
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Singapore General HospitalNovem Healthcare Pte LtdTerminatedSuperficial Surgical Site InfectionSingapore
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Halmstad County HospitalCompleted
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Region SkaneVinnovaCompleted
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Population Health Research InstituteCompletedSurgical Site InfectionsCanada
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University of RochesterSage Products, Inc.Completed
Clinical Trials on Bundle of measures to decreased SSI
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Hospital General Universitario ElcheUnknownSurgical Site InfectionSpain
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Centre Hospitalier Universitaire DijonRecruitingFocal Acute Respiratory Distress SyndromeFrance
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AO Clinical Investigation and Publishing DocumentationTerminatedSurgical Site InfectionUnited States, Argentina, Korea, Republic of, Germany, Spain, Romania
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University Hospital, GenevaUnknownSleep | Intensive Care Unit Syndrome
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Statens Serum InstitutBill and Melinda Gates Foundation; Larix A/S; CCBR Clinical ResearchCompletedImmunization, BoosterDenmark
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Hospital de GranollersCompletedColorectal Neoplasms | Surgical Wound InfectionSpain
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Karolinska InstitutetKarolinska University Hospital; University Hospital, Linkoeping; Danderyd Hospital and other collaboratorsTerminated
-
Centre Hospitalier Universitaire de NiceNot yet recruitingHealth Care Associated Infection
-
Chinese University of Hong KongThe Queen Elizabeth HospitalUnknown
-
Wills EyeMerck Sharp & Dohme LLCCompleted