Colorectal Surgical Site Infection | NCT05355376

Studies
Colorectal Surgical Site Infection

NCT05355376

Sponsor

Centro Hospitalar Universitário Lisboa Norte

Status

Completed

Last Update Posted

May 5, 2022Actual

Enrollment

1,139Actual

Phase

Not provided

Conditions

Surgical Site Infection

Interventions

Bundle of measures to decreased SSI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Jul 31, 2021Actual

First Submitted Date

Apr 11, 2022

First Submission Date that Met QC Criteria

Apr 26, 2022

First Posted Date

May 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2022

Last Update Posted Date

May 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aldara Filipa Peixoto Faria, Principal investigator, Centro Hospitalar Universitário Lisboa NortePrincipal Investigator

Lead Sponsor

Centro Hospitalar Universitário Lisboa NorteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,139Actual

Name	Type	Description	Arm Group Labels	Other Names
Bundle of measures to decreased SSI	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of surgical site infections	Evaluate the variation of surgical site infections during a period of 5 years	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided