Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents in Patients Patients With Neuromotor Disability : a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Success at 12 months after surgery
研究概览
简要总结
People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at high risk of osteomyelitis-associated pressure ulcers.
The management of osteomyelitis-associated pressure ulcers is controversial. In our center, patients benefit from a one stage surgical management with bone shaving and flap covering osteitis of pressure ulcer to perform wound closing. Surgery is followed by an antibiotic treatment, secondarily adapted to intraoperative samples.
The aim of this study is to describe the cohort and to identify factors associated with failure (or success) in this frail population.
详细描述
This is a prospective, monocentric, cohort study of neurological disabled inpatients subjects treated in the perioperative disability unit (UPOH) of our university hospital for osteomyelitis-associated pressure ulcer by surgical flaps and anti bacterial agents.
All eligible inpatient subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers by surgical flaps will be consecutively included.
Patients are followed up in consultation at 30 or 45 days after surgery, and in consultation or teleconsultation at 12 months after surgery.
Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological, and physiological examinations. Data related to sitting, nutrition, spasticity, bladder and bowel disorders, bacteriological sampling and antibiotic treatments will be collected.
This is a routine care study; no procedures are added for research purposes. It is an ancillary study to the NO-AGING study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients >= 18 years old ;
- •Treated in the Perioperative Disability Unit (UPOH) of the Physical Medicine and Rehabilitation Department of our university hospital;
- •Admitted for the treatment of an osteomyelitis-associated pressure ulcer by surgical flap;
- •Having a neuromotor disability;
- •No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it;
- •Affiliation to a social security scheme.
排除标准
- •Under court protection.
结局指标
主要结局
Success at 12 months after surgery
时间窗: 12 months after surgery
Success is defined as the absence of surgical revision, the absence of additional antibiotic therapy, and the absence of local care at the surgical site.
次要结局
- Success at 30-45 days after surgery(30-45 days after surgery (depening on the surgical technique))
- Description of the patients' bacteriological tests(Through hospital admission, up to 7 days after surgery)
- Death(12 months after surgery)