Thoracolumbar fracture
Conditions
Interventions
Trial Group:Pre-treatment of GSVF sponge (irradiation sterilization) before surgery, packing at bleeding site during surgery (packing time 5-10 min), replace if completely soaked by blood
Control Group 1:Use gelatin sponge following the same procedure as the trial group
Control Group 2:Use hemostatic gauze following the same procedure as the trial group
Sponsors
Xi'an Honghui Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with thoracolumbar fractures by imaging examinations (X-ray, CT, MRI) and requiring open reduction, decompression and internal fixation, with a TLICS score > 4. 2.Aged from 18 to 65 years old; 3.Patients who signed the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Patients complicated with other spinal diseases such as tumor, infection, deformity (e.g., scoliosis), or with a previous surgical history; 2.Those complicated with severe underlying diseases including cardiovascular and cerebrovascular diseases, hepatic or renal insufficiency, and unable to tolerate surgical operation. 3.History of allergy related to components of hemostatic materials (specific components: collagen, gelatin, polyethylene glycol); 4.Patients with intraoperative cerebrospinal fluid leakage; 5.Patients with abnormal initial coagulation function tests (including prothrombin time, prothrombin time activity, international normalized ratio, activated partial thromboplastin time, thrombin time, fibrinogen, platelet count, etc.), who are deemed ineligible for enrollment in this study by the attending physician after re-examination; 6.Women planning pregnancy, pregnant women and lactating women; 7.Patients with a definite preoperative infectious focus (such as skin and soft tissue infection, urinary tract infection, pneumonia, etc.), or laboratory examinations suggesting systemic infection (C-reactive protein >= 10 mg/L and procalcitonin >= 0.5 ng/mL), as well as those complicated with microvascular complications including diabetic foot and recurrent skin infection. 8.Patients who have participated in other clinical studies within the past 3 months; 9.Patients deemed by the investigator to have other factors rendering them unsuitable for participation in this clinical trial, including patients with tumors, with the impact on coagulation function as the primary screening criterion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostasis time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood loss volume;Hemostatic efficacy assessment;Postoperative drainage volume;Postoperative pain score (VAS, JOA);Hospital length of stay;Postoperative functional recovery; | — |
Countries
China
Contacts
Public ContactYan Liang
Xi'an Honghui Hospital
Outcome results
None listed