Depression, Malnutrition, Surgical Site Infections
Conditions
Keywords
surgical site infection, depression, malnutrition, orthopedic surgery, mood disorders, infection management, prospective study
Brief summary
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
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.
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major Depressive Episodes | Weeks 6, Month 3, Month 6 and Month 12 | Incidence of major depressive episodes as defined by the DSM V criteria, screened using the Major Depression Inventory (MDI) score. This will be assessed at baseline (M0) and at subsequent follow-up visits (Weeks 6, Month 3, Month 6 and Month 12). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Socio-Demographic and Clinical Characteristics | Baseline (day 0) and 12 months (M12) | Collection of socio-demographic data including age, sex, employment status, medical and surgical history, and smoking status at baseline and at the end of the study (M12). |
| Incidence of Malnutrition and Its Risk Factors | 12 months | \- Malnutrition is defined by weight loss ≥ 5% in 1 month, ≥ 10% in 6 months, or ≥ 10% compared to usual weight before illness (HAS definition); BMI \< 18.5 kg/m². |
| Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety | Baseline (Day 0), Week 6, Month 3, Month 6, and Month 12 | \- Success of infection treatment defined by the cessation of ongoing antibiotic therapy. |
Countries
France
Contacts
CONTACTBenjamin BOUYER, PROF
CONTACTRomain HUGUET
PRINCIPAL_INVESTIGATORBenjamin BOUYER, PROF
University Hospital, Bordeaux
Outcome results
None listed