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
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
300
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.
CHU de Bordeaux
Bordeaux, France
RECRUITINGIncidence of Major Depressive Episodes
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).
Time frame: Weeks 6, Month 3, Month 6 and Month 12
Socio-Demographic and Clinical Characteristics
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).
Time frame: Baseline (day 0) and 12 months (M12)
Incidence of Malnutrition and Its Risk Factors
\- 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.
Time frame: 12 months
Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety
\- Success of infection treatment defined by the cessation of ongoing antibiotic therapy.
Time frame: Baseline (Day 0), Week 6, Month 3, Month 6, and Month 12
Incidence of Malnutrition and Its Risk Factors
Monitoring current nutritional management (oral supplements, nutritional assessments conducted).
Time frame: 12 months
Incidence of Malnutrition and Its Risk Factors
\- Biological criteria for malnutrition: levels of albumin, pre-albumin, folate (B9), and vitamin B12.
Time frame: 12 months
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Incidence of Malnutrition and Its Risk Factors
\- Assessment using the Mini Nutritional Assessment (MNA) questionnaire.
Time frame: 12 months
Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety
\- Modifications in infection management due to malnutrition and depression events: treatment discontinuation, therapeutic changes.
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
\- Quality of life scales: SF-36 (SF-36v2® Health Survey ©) and EQ-5D-5L (EuroQol Research Foundation©). These parameters will be assessed at baseline (Day 0) and during follow-up visits (W6, M3, M6, and M12).
Time frame: Baseline (Day0), Week 6, Month 3, Month 6, and Month 12