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

University Hospital of Bordeaux

Status: Not yet enrolling

Conditions: Malnutrition; Depression; Surgical Site Infections

Treatments: Other: Data collection and self-administered questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT07125196

CHUBX 2024/09

Details and patient eligibility

About

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

Full description

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Surgical site infection

Other group

Description:

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

Treatment:

Other: Data collection and self-administered questionnaire