An observational study in Osteomyelitis Tibia and Surgical Site Infection, sponsored by University Medical Centre Ljubljana. Completed. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by University Medical Centre Ljubljana · Observational
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.
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.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's enrollment of 86 is below the median of 239 across 135 observational studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
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Patients admitted to the Department of Traumatology at University Clinical Centre Ljubljana were included after written informed consent.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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).
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.
Time frame: 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.,).
Time frame: 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.
Time frame: perioperative period
No study locations are listed for this record.
Ran from Jan 2011 to primary completion in Dec 2013, 35 months.
Of 65 non-industry observational studies under Surgical Wound Infection, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 53. This study's 35 months is above that.
Counting every sponsor, half of 68 studies reached it within 21 months; a quarter within 9 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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