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

NCT03459261 | Completed

• 1 other identifier: 20120130
• Study Type: observational
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteomyelitis Tibia; Surgical Site Infection

Keywords

osteomyelitis; tibial fracture; cytokines; PCT; CRP; albumin

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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-α (Milenia Biotec, Germany), IL-6 and IL-10 (Thermo Scientific, USA) were measured according to the manufacturer's instructions.

  perioperative period

Study Arms (2)

POM

post-traumatic osteomyelitis group (POM), the participants who developed post-traumatic osteomyelitis after primary surgical treatment and were taken blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4). Patients were included in POM group after additional assessment of meeting the CDC/NHSN surveillance definition criteria for osteomyelitis: positive intraoperative withdrawal bone and soft tissue sample, types of cultured bacteria, histopathologic proof of osteomyelitis and clinical signs of surgical site infection.

Diagnostic Test: blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)

NO POM

No POM group, the participants who did not develop postraumatic osteomyelitis to tibia after primary surgical treatment and were taken blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4) in follow up interval of 6 months /control group/. Patients were included in No POM group after assessment of not meeting the CDC/NHSN surveillance definition criteria for osteomyelitis.

Interventions

blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4) DIAGNOSTIC_TEST

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).

POM

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Department of Traumatology at University Clinical Centre Ljubljana were included after written informed consent.

You may qualify if:

• high-energy injury to proximal, shaft or distal tibia,
• tibial fracture requiring primary surgical treatment /ORIF

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Prof. Alojz Ihan, MD, Ph.D, Institute of Microbiology and Immunology, Ljubljana, Slovenia: collaborator

MeSH Terms

Conditions

Surgical Wound Infection; Osteomyelitis; Tibial Fractures

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of HDU at Traumatology Department Matjaž Groznik, MD, Specialist in Traumatology and Intensive Care Medicine

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: March 8, 2018
• Study Start: January 1, 2011
• Primary Completion: December 31, 2013
• Study Completion: January 31, 2014
• Last Updated: March 9, 2018

Record last verified: 2018-03