Surgical Site InfectionNCT05355376
Colorectal Surgical Site Infection
An observational study of Surgical Site Infection, run by Centro Hospitalar Universitário Lisboa Norte.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Bundle of measures to decreased SSI
- Type of treatment
- Surgery or procedure
- How many people
- 1,139 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients submitted to eletive colorectal surgery, by laparotomy, during a period of 5 years, in our colorectal department
Who may be able to join
- Patients submitted to elective colorectal surgery between 2016, january 1 and 2020, december 31
- Age > 18 years
- At least 30 days of follow-up
Who cannot join
- Patients submitted to urgent colorectal surgery
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgical Site Infection
- Being tested
- Bundle of measures to decreased SSI
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bundle of measures to decreased SSIProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of surgical site infections
Evaluate the variation of surgical site infections during a period of 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jan 2016
- Primary completion31 Dec 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Universitário Lisboa Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aldara Filipa Peixoto Faria, Centro Hospitalar Universitário Lisboa Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355376
- Sponsor's protocol ID
- 0003
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Surgical Site Infection: a Cohort Study About How Can we Decrease it
- ClinicalTrials.gov ID
- NCT05355376
- Acronym / sponsor ID
- 0003
- Conditions
- Surgical Site Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,139 participants (actual)
- Lead sponsor
- Centro Hospitalar Universitário Lisboa NorteUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted to eletive colorectal surgery, by laparotomy, during a period of 5 years, in our colorectal department
Key inclusion criteria (3 listed)
- Patients submitted to elective colorectal surgery between 2016, january 1 and 2020, december 31
- Age > 18 years
- At least 30 days of follow-up
Key exclusion criteria (1 listed)
- Patients submitted to urgent colorectal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bundle of measures to decreased SSI | Procedure or surgery | – |
Primary outcome
The rate of surgical site infections
Time frame: 5 years
Evaluate the variation of surgical site infections during a period of 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by Centro Hospitalar Universitário Lisboa Norte.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of surgical site infections (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.