跳至主要内容
临床试验/NCT03010293
NCT03010293已完成不适用

Pressure Ulcer-associated Osteomyelitis: Retrospective Evaluation of a Two-stage Surgical Strategy (Debridement With Vacuum-assisted Closure Therapy and Reconstruction) With Prolonged Antimicrobial Therapy

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
Failure of a two-stage surgical strategy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis

研究概览

简要总结

Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe complication with a poorly known management, and is associated with a high rate of relapse, leading to a high-burden in hospital bed-days, financial cost, surgical intervention, antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone and joint infection management, the medical and surgical strategies are systematically discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to evaluate this complex approach and to determine risk factors of treatment failure in order to improve patient management, focusing on optimization of empirical antimicrobial therapy after each surgical stage, delay between the two surgical stage, and duration of antimicrobial therapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (i.e age ≥ 18 year-old) with a osteomyelitis complication following a pressure ulcer who benefited from a two-stage surgical strategy

排除标准

  • 未提供

结局指标

主要结局

Failure of a two-stage surgical strategy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis

时间窗: 2 years after antibiotic therapy disruption

Treatment failure will include: 1) local clinical and/or microbiological relapse; and/or 2) need for additional surgery after surgical reconstruction by muscular flap; and/or 3) death of septic origin.

次要结局

  • Risk factor for treatment failure of a two-stage surgical strategy with prolonged antimicrobial therapy in patient with ischiatic or sacral pressure ulcer-associated osteomyelitis(2 years after antibiotic therapy disruption)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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