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

NCT07125196 | Recruiting

• 1 other identifier: CHUBX 2024/09
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgical Site Infections; Depression; Malnutrition

Keywords

surgical site infection; depression; malnutrition; orthopedic surgery; mood disorders; infection management; prospective study

Outcome Measures

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).

  Weeks 6, Month 3, Month 6 and Month 12

Secondary Outcomes (8)

• Socio-Demographic and Clinical Characteristics

  Baseline (day 0) and 12 months (M12)

• Incidence of Malnutrition and Its Risk Factors

  12 months

• Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety

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

• Incidence of Malnutrition and Its Risk Factors

  12 months

• Incidence of Malnutrition and Its Risk Factors

  12 months

Study Arms (1)

Surgical site infection

OTHER

Patients treated for surgical site infection (prosthetic surgery and trauma surgery)

Other: Data collection and self-administered questionnaire

Interventions

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.

Surgical site infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection; Depression; Malnutrition; Mood Disorders

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Nutrition Disorders; Nutritional and Metabolic Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Benjamin BOUYER, PROF

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin BOUYER, PROF

CONTACT

+335 56 79 87 18; b.bouyer@chu-bordeaux.fr

Romain HUGUET

CONTACT

romain.huguet@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 15, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

FR (1)