Health TrialsbyHealthPanel

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

ConditionsSurgical Site InfectionsDepressionMalnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient >18 years old

Prosthetic limb surgery

Spinal surgery

Traumatology: Osteosynthesis of peripheral limbs or spine

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Data collection and self-administered questionnaire

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Surgical site infectionOther 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Weeks 6, Month 3, Month 6 and Month 12

Secondary outcomes

1

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)
2

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
3

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
4

Incidence of Malnutrition and Its Risk Factors

Monitoring current nutritional management (oral supplements, nutritional assessments conducted).

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Source ClinicalTrials.gov
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