NCT06480344

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 24, 2024

Last Update Submit

June 27, 2024

Conditions

Keywords

Surgical site infectionNNIS indexPost-operative infection

Outcome Measures

Primary Outcomes (1)

  • Occurence of surgical site infection

    Wheter or not patients developed surgical site infection

    1 year

Study Arms (2)

Case

Patients who developed surgical site infection.

Controls

Patients who did not developed surgical site infection.

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital de l'Université d'Etat d'Haiti

Port-au-Prince, Ouest, Haiti

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

March 1, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

June 28, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations