NCT03459261

Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures and Biomarkers

Can we Improve the Treatment of Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures by Using Perioperative Immunoinflammatory Markers?

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 86 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Osteomyelitis Tibia
• Surgical Site Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)	Laboratory analyses of peripheral venous blood on admission (blood sample ADD), 24 hours after surgery (blood sample POD1) and fourth-day after surgery (blood sample POD4) included biochemical analysis, complete blood count, C-reactive protein (CPR), procalcitonin (PCT), albumin/protein level, prothrombin time and international normalized ratio (INR) (only on admission) and for determination of cytokines: tumor necrosis factor alpha (TFN-α), interleukin-6 (IL-6), interleukin-10 (IL-10).

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-12-31
• Completion: 2014-01-31
• First posted: 2018-03-08
• Last updated: 2018-03-09