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NCT Number: NCT07125196

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

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

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Key information

Conditions

Surgical Site Infections Behavior Behavioral Symptoms Depression Infections Malnutrition Mental Disorders Mood Disorders Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, France

Location status: Recruiting

Location contact

Benjamin BOUYER, PROF

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Major Depressive Episodes

    Time frame: 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 outcomes

  1. Socio-Demographic and Clinical Characteristics

    Time frame: 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).

  2. Incidence of Malnutrition and Its Risk Factors

    Time frame: 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.

  3. Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety

    Time frame: Baseline (Day 0), Week 6, Month 3, Month 6, and Month 12

    • Success of infection treatment defined by the cessation of ongoing antibiotic therapy.

  4. Incidence of Malnutrition and Its Risk Factors

    Time frame: 12 months

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

  5. Incidence of Malnutrition and Its Risk Factors

    Time frame: 12 months

    • Biological criteria for malnutrition: levels of albumin, pre-albumin, folate (B9), and vitamin B12.

  6. Incidence of Malnutrition and Its Risk Factors

    Time frame: 12 months

    • Assessment using the Mini Nutritional Assessment (MNA) questionnaire.

  7. Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety

    Time frame: Baseline ( Day 0), Week 6, Month 3, Month 6, and Month 12

    • Modifications in infection management due to malnutrition and depression events: treatment discontinuation, therapeutic changes.

  8. Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety

    Time frame: Baseline (Day0), Week 6, Month 3, Month 6, and Month 12

    • 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin BOUYER, PROF

CONTACT

[email protected]

+335 56 79 87 18

Romain HUGUET

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: ISODEP

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Aug 15, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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