Actively Recruiting
Incidence of Depression and Its Complications After Surgical Site Infection - ISODEP.
Led by University Hospital, Bordeaux · Updated on 2026-02-09
300
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the occurrence of depression and related complications like malnutrition in patients who develop surgical site infections after orthopedic surgeries. The study is observational and will take place over five years at a single center, the University Hospital of Bordeaux. It aims to improve how these complications are managed and prevented in patients treated for infections following prosthetic and trauma surgeries on limbs and the spine. Participants will be patients treated for surgical site infections after orthopedic procedures on limbs or spine, including prosthetic surgeries and trauma-related osteosynthesis. Data will be collected prospectively through clinical records, radiological exams, and patient-completed questionnaires about psychological state and nutritional status, based on standard care. The study includes a planned three-year follow-up period to monitor these outcomes. During the study, participants will have their general health, demographic information, septic condition, psychiatric disorders, and nutrition assessed at multiple time points including baseline, 6 weeks, 3 months, 6 months, and 12 months. The main outcome is the incidence of major depressive episodes assessed at these intervals. Secondary outcomes include socio-demographic and clinical characteristics, incidence and risk factors of malnutrition, and how malnutrition and depression affect infection treatment efficacy and safety. The total study duration with follow-up is five years, ensuring comprehensive monitoring and data collection.
CONDITIONS
Brief Title
Incidence of Depression and Its Complications After Surgical Site Infection - ISODEP.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years old or older
- Patient treated for surgical site infection after orthopedic surgery on limbs or spine
- Surgical site infection includes prosthetic limb surgery, spinal surgery, or trauma osteosynthesis of limbs or spine
You will not qualify if you...
- Patient under guardianship, curatorship, or any legal protection
- Pregnant or breastfeeding woman
- Person deprived of liberty by judicial or administrative decision
- Person requiring legal representative consent for psychiatric treatment under duress
- Person unable to give consent
- Patient not affiliated with a social protection scheme
- History of diagnosed depression, hospitalization for depressive disorders, or use of mood-regulating treatments
- Initial BMI less than 18.5
- Presence of cancer, ongoing inflammatory disease, or condition causing chronic undernutrition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants treated for surgical site infection are observed while data on their clinical condition, psychological state, and nutritional status is collected through standard care and self-administered questionnaires.
Assessments at baseline, Week 6, Month 3, Month 6, Month 12, and continued follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
CHU de Bordeaux
Bordeaux, France
Actively Recruiting
Research Team
B
Benjamin BOUYER, PROF
R
Romain HUGUET
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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