Incidence of Depression and Its Complications After Surgical Site Infection - ISODEP.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of Major Depressive Episodes
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Surgical site infection
Patients treated for surgical site infection (prosthetic surgery and trauma surgery)
干预措施: Data collection and self-administered questionnaire (Other)
结局指标
主要结局
Incidence of Major Depressive Episodes
时间窗: 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).
次要结局
- 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 (Day0), Week 6, Month 3, Month 6, and Month 12)
- Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety(Baseline (Day 0), Week 6, Month 3, Month 6, and Month 12)
- Prognostic Significance of Malnutrition and Depression on Infection Treatment Efficacy and Safety(Baseline ( Day 0), Week 6, Month 3, Month 6, and Month 12)