Analysis of Risk Factors for Surgical Site Infections in... | NCT06480344

Studies
Analysis of Risk Factors for Surgical Site Infections in Patients With Acute Abdomen at Hospital of State University of Haiti

NCT06480344

Sponsor

University of Haiti

Status

Completed

Last Update Posted

Jun 28, 2024Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Surgical Site Infection
Post-Op Infection

Interventions

Not provided

Countries

Haiti

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

Jun 2024

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

Mar 1, 2021Actual

Primary Completion Date

Aug 30, 2021Actual

Completion Date

Aug 30, 2021Actual

First Submitted Date

Jun 24, 2024

First Submission Date that Met QC Criteria

Jun 27, 2024

First Posted Date

Jun 28, 2024Actual

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

Jun 27, 2024

Last Update Posted Date

Jun 28, 2024Actual

Name	Class
Christopher Williams Valsaint	UNKNOWN
Axler Jean-Paul	UNKNOWN

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

The purpose of this study is to identify the risk factors associated with surgical site infection.

Detailed Description

87 patients medical records from January 2018 to December 2020 will be analyzed to detect the risk factors linked to the occurence of surgical site infection. Then the strength of their association with surgical site infection will be determined via multivariate 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

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Case		Patients who developed surgical site infection.
Controls		Patients who did not developed surgical site infection.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurence of surgical site infection	Wheter or not patients developed surgical site infection	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female or male patients over 12 years of age.
Admitted to the Surgery Department for acute surgical abdomen and having undergone surgery

Exclusion Criteria:

Patients who have undergone abdominal surgery for urological or gynecological pathologies
Files with missing information on preoperative, operative and post-operative arrangements

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The participants selected in our study include those who have developed an infection at the operating site (case) as well as those who have not developed it (controls) following acute abdominal surgery diagnosed in post-op room at the surgery department of The State University of Haiti, from January 2018 to December 2022.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital de l'Université d'Etat d'Haiti		Port-au-Prince	Ouest		Haiti

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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