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

Surgical Site Infection Clinical Trial

— POMTIBIAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459261
• Other study ID #: 20120130
• Status: Completed
• Phase: N/A
• First received: February 10, 2018
• Last updated: March 8, 2018
• Start date: January 1, 2011
• Est. completion date: January 31, 2014

Study information

• Verified date: March 2018
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 31, 2014
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• high-energy injury to proximal, shaft or distal tibia,

• tibial fracture requiring primary surgical treatment /ORIF

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteomyelitis
• Osteomyelitis Tibia
• Surgical Site Infection
• Surgical Wound Infection
• Tibial Fractures

Intervention

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-a), interleukin-6 (IL-6), interleukin-10 (IL-10).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Prof. Alojz Ihan, MD, Ph.D, Institute of Microbiology and Immunology, Ljubljana, Slovenia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of biomarkers CRP, PCT, WBC on ADD, POD1, POD4	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.	perioperative period
Primary	Assessment of patients' immune status	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.,).	perioperative period
Primary	Determination of cytokines level in serum: tumor necrosis factor (TFN-alpha), interleukin-6 (IL-6), interleukin-10 (IL-1) and lymphocyte populations	Cytokine concentrations were measured by commercially available enzyme-linked immunosorbent assay (ELISA) kits. TNF-a (Milenia Biotec, Germany), IL-6 and IL-10 (Thermo Scientific, USA) were measured according to the manufacturer's instructions.	perioperative period