NCT05355376

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,139

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

5 years

First QC Date

April 11, 2022

Last Update Submit

April 29, 2022

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

  • The rate of surgical site infections

    Evaluate the variation of surgical site infections during a period of 5 years

    5 years

Interventions

Bundle of measures to decreased SSIPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients submitted to eletive colorectal surgery, by laparotomy, during a period of 5 years, in our colorectal department

You may qualify if:

  • Patients submitted to elective colorectal surgery between 2016, january 1 and 2020, december 31
  • Age \> 18 years
  • At least 30 days of follow-up

You may not qualify if:

  • Patients submitted to urgent colorectal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 11, 2022

First Posted

May 2, 2022

Study Start

January 1, 2016

Primary Completion

December 31, 2020

Study Completion

July 31, 2021

Last Updated

May 5, 2022

Record last verified: 2022-04