Incidence of Depression and Its Complications After Surgical Site Infection - ISODEP.

NCT ID: NCT07125196

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2029-07-31

Brief Summary

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Surgical-site infection (SSI) in orthopedic surgery is a serious and frequent complication with many consequences on the patient's quality of life. This study aims to describe the incidence of depression and its complications like malnutrition in patients followed for surgical site infection to allow their best management and prevention

Detailed Description

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We will conduct a monocentric (department orthopedic surgery, University Hospital of Bordeaux, France) prospective observational study for 5 years, involving all patients treated for surgical site infection (prosthetic surgery and trauma surgery) The data collected will concern the general condition of the patients, demographic data, information about septic condition, psychiatric disorders, or nutritional conditions, as well as the care provided. A three-year follow-up will be planned

Conditions

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Surgical Site Infections Depression Malnutrition

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Surgical site infection

Patients treated for surgical site infection (prosthetic surgery and trauma surgery)

Group Type OTHER

Data collection and self-administered questionnaire

Intervention Type OTHER

Exhaustive collection of data in a health data warehouse: collection of clinical, radiological examinations (standard of care), and self-administered questionnaire: a questionnaire concerning the psychological state of the patients (questionnaire according to DSM V) and a questionnaire on nutritional status.

Interventions

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Data collection and self-administered questionnaire

Exhaustive collection of data in a health data warehouse: collection of clinical, radiological examinations (standard of care), and self-administered questionnaire: a questionnaire concerning the psychological state of the patients (questionnaire according to DSM V) and a questionnaire on nutritional status.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient \>18 years old
* Patient treated in infectiology for surgical site infection after orthopedic surgery of the limbs or spine:

* Prosthetic limb surgery
* Spinal surgery
* Traumatology: Osteosynthesis of peripheral limbs or spine

Exclusion Criteria

* Patient under guardianship or curatorship,
* Pregnant, breastfeeding woman
* Person deprived of liberty by judicial or administrative decision,
* Person undergoing psychiatric treatment under duress requiring the consent of the legal representative.
* Person unable to express their consent,
* Person under legal protection,
* Patient not affiliated to a social protection scheme.
* Patient with a history of diagnosed depression, hospitalization for depressive disorders or taking mood-regulating treatments.
* An initial BMI of less than \< 18.5, the existence a cancerous pathology, an ongoing inflammatory disease, a pathology responsible for chronic undernutrition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin BOUYER, PROF

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU de Bordeaux

Bordeaux, , France

Site Status

Countries

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France

Central Contacts

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Benjamin BOUYER, PROF

Role: CONTACT

+335 56 79 87 18

Romain HUGUET

Role: CONTACT

Facility Contacts

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Benjamin BOUYER, PROF

Role: primary

Other Identifiers

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CHUBX 2024/09

Identifier Type: -

Identifier Source: org_study_id

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