Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical site infection | Other | Patients treated for surgical site infection (prosthetic surgery and trauma surgery) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection and self-administered questionnaire | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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). | Weeks 6, Month 3, Month 6 and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (day 0) and 12 months (M12) |
| Incidence of Malnutrition and Its Risk Factors |
Not provided
Inclusion Criteria:
Patient >18 years old
Patient treated in infectiology for surgical site infection after orthopedic surgery of the limbs or spine:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin BOUYER, PROF | Contact | +335 56 79 87 18 | b.bouyer@chu-bordeaux.fr | |
| Romain HUGUET | Contact | romain.huguet@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin BOUYER, PROF | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Recruiting | Bordeaux | France |
Not provided
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D003863 | Depression |
| D044342 | Malnutrition |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
- 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. |
| 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. | 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). | 12 months |
| Incidence of Malnutrition and Its Risk Factors | - Biological criteria for malnutrition: levels of albumin, pre-albumin, folate (B9), and vitamin B12. | 12 months |
| Incidence of Malnutrition and Its Risk Factors | - Assessment using the Mini Nutritional Assessment (MNA) questionnaire. | 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. | 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). | Baseline (Day0), Week 6, Month 3, Month 6, and Month 12 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001523 | Mental Disorders |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |