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Recruiting NCT07125196

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

No phase Interventional Surgical Site Infections Depression Malnutrition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection and self-administered questionnaire.
Who it may be relevant to
Registry conditions: Surgical Site Infections, Depression, Malnutrition. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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

Interventions

  • Other 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.

Primary outcome measures

  • Incidence of Major Depressive Episodes [Time frame: Weeks 6, Month 3, Month 6 and Month 12]
Secondary outcome measures (8)
  • Socio-Demographic and Clinical Characteristics [Time frame: Baseline (day 0) and 12 months (M12)]
  • Incidence of Malnutrition and Its Risk Factors [Time frame: 12 months]
  • Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety [Time frame: Baseline (Day 0), Week 6, Month 3, Month 6, and Month 12]
  • Incidence of Malnutrition and Its Risk Factors [Time frame: 12 months]
  • Incidence of Malnutrition and Its Risk Factors [Time frame: 12 months]
  • Incidence of Malnutrition and Its Risk Factors [Time frame: 12 months]
  • Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety [Time frame: Baseline ( Day 0), Week 6, Month 3, Month 6, and Month 12]
  • Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety [Time frame: Baseline (Day0), Week 6, Month 3, Month 6, and Month 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Bordeaux — Bordeaux

Identifiers

NCT: NCT07125196 · CHUBX 2024/09

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗