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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05355376
Other study ID # 0003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date July 31, 2021

Study information

Verified date April 2022
Source Centro Hospitalar Universitário Lisboa Norte
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Because of that the investigators created a care bundle of measures in order to improve the outcomes.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1139
Est. completion date July 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Bundle of measures to decreased SSI


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centro Hospitalar Universitário Lisboa Norte

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of surgical site infections Evaluate the variation of surgical site infections during a period of 5 years 5 years
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