Can we Improve the Treatment of Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures by Using Perioperative Immunoinflammatory Markers?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Assessment of patients' immune status
研究概览
简要总结
The present trial was aimed to identify which biomarkers could be associated in perioperative period after surgical treatment of tibial fracture to the development of POM.
详细描述
Early diagnosis of acute posttraumatic osteomyelitis (POM) is of vital importance for avoiding devastating complications. Diagnosing POM is difficult due to the lack of a highly specific and sensitive test, such as in myocardial infarct, stroke and intracranial bleeding. Serum inflammatory markers, C-reactive protein (CRP), procalcitonin (PCT), white blood cells (WBC) can support clinical findings but they are not able to differentiate between inflammatory response to infection and the host response to non-infection insult with high specificity and sensitivity.
The prospective nonrandomised cohort study included 86 patients after high-energy injury to the shin requiring primary surgical treatment (open or closed reduction and internal fixation of tibial fracture). Values of the biochemical and immunoinflammatory profile were measured on admission (ADD), first postoperative day (POD1) and fourth-postoperative day (POD4).
The objectives of the study were to investigate that the biochemical and immunoinflammatory profile could facilitate postoperative monitoring, guide the antibiotic treatment and timing of revision surgery.
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •high-energy injury to proximal, shaft or distal tibia,
- •tibial fracture requiring primary surgical treatment /ORIF
排除标准
- •ankle fracture,
- •patella fracture,
- •avulsion fracture of the knee,
- •malignant neoplasm and pathological tibial fracture,
- •systemic autoimmune disease of connective tissue,
- •immature patients under 15 years of age (children),
- •immunocompromised patients.
结局指标
主要结局
Assessment of patients' immune status
时间窗: perioperative period
Whole venous blood was collected into vacutainer tubes containing EDTA. Samples were processed for flow cytometry. For surface staining, the standard whole-blood staining methodology as prescribed by the manufacturer (BDBiosciences) was used. For detecting regulatory T cells, samples were stained for surface antigens with a mix of anti-CD25-PE/ anti-CD127-APC/ anti-CD4-PE-Cy™7. All antibodies were obtained from BDBiosciences (Mountain View, Ca, USA). Cells were analyzed on FACSCantoII™ Flow Cytometer (BDBiosciences) equipped with blue (488-nm solid-state) and red (633-nm helium-neon) laser. Digital data was acquired with FACSDiva software (BDBiosciences) and analyzed using FlowJo software (Tree Star Inc.,).
Measurement of biomarkers CRP, PCT, WBC on ADD, POD1, POD4
时间窗: perioperative period
WBC count (reference range 4-10 x 109/L), WBC differential (neutrophil count 1.50-7.40 x 109/L, lymphocyte count 1.10-3.50 x 109/L) and hematocrit (reference range 0.390-0.500) were analyzed with a hematological blood analyzer LH75 (Beckman Coulter). The immunocytochemic analyzer Modular Analytics SWE (Roche Diagnostics) was used for serum samples analysis. The serum concentration of CRP (reference range 0-5mg/L) was measured by the immunoturbidimetric method, PCT (reference range 0-0.5μg/L) by the electrochemiluminescence method and albumins (reference range 35-52g/L) by the bromcresol green method.
Determination of cytokines level in serum: tumor necrosis factor (TFN-alpha), interleukin-6 (IL-6), interleukin-10 (IL-1) and lymphocyte populations
时间窗: perioperative period
Cytokine concentrations were measured by commercially available enzyme-linked immunosorbent assay (ELISA) kits. TNF-α (Milenia Biotec, Germany), IL-6 and IL-10 (Thermo Scientific, USA) were measured according to the manufacturer's instructions.
次要结局
未报告次要终点
研究者
Matjaž Groznik, MD
Head of HDU at Traumatology Department Matjaž Groznik, MD, Specialist in Traumatology and Intensive Care Medicine
University Medical Centre Ljubljana