Surgical Site InfectionNCT06480344
Analysis of Risk Factors for Surgical Site Infections in Patients With Acute Abdomen at Hospital of State University of Haiti
An observational study of Surgical Site Infection and Post-Op Infection, run by University of Haiti at 1 site in Haiti.
Trial summary
The purpose of this study is to identify the risk factors associated with surgical site infection. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Post-Op Infection
- How many people
- 87 participants
- Where
- 1 siteHaiti
- Study dates
- 1 Mar 2021to 30 Aug 2021
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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.
Who may be able to join
- Female or male patients over 12 years of age.
- Admitted to the Surgery Department for acute surgical abdomen and having undergone surgery
Who cannot join
- Patients who have undergone abdominal surgery for urological or gynecological pathologies
- Files with missing information on preoperative, operative and post-operative arrangements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors Associated With the Occurrence of Surgical Site Infections (SSI) in Patients Operated for Acute Abdomen at Hôpital de l'Université d'Etat d'Haiti (HUEH) From January 2018 to December 2020
The purpose of this study is to identify the risk factors associated with surgical site infection.
Read the 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.
- Conditions
- Surgical Site Infection, Post-Op Infection
- Keywords
- Surgical site infection, NNIS index, Post-operative infection
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients who developed surgical site infection. | |
| Controls | Patients who did not developed surgical site infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of surgical site infection
Wheter or not patients developed surgical site infection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start1 Mar 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haiti
- Sponsor type
- University, hospital or other
- Collaborators
- Christopher Williams Valsaint, Axler Jean-Paul
- Responsible party
- Principal investigator, Thaimye Joseph, University of Haiti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480344
- Sponsor's protocol ID
- JTCVCC001
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No