Burn wound. Burn
Conditions
Interventions
Intervention group: the first group, which receives 20 mg/kg tranexamic acid injection during skin debridement. Control group: who receive 10 mg of normal saline injection.
Sponsors
Karaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
15 Years to 55 Years
Inclusion criteria
Inclusion criteria: Patients between 15 -55 years old over than 20 percent of surface of body Need skin debridement Does not require special medical services such as hospitalization in ICU Not breastfeeding or pregnant Do not have a history of hypercoagulopathy or thrombotic events Do not suffer from bleeding disorders Not accompanied by blunt abdominal trauma or head injury No electric or chemical burn No third degree of burn
Exclusion criteria
Exclusion criteria: Systolic blood pressure over than 200 mmhg Disruption of coagulation factors Have disturbance in Kidney function tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To check the amount of bleeding, the amount of hemoglobin and hematocrit will be measured before the surgery and 24 hours after the surgery and will be compared with the value measured before the study. The amount of pack cell received by the patients and the duration of their stay in the hospital will be compared between the control and intervention groups. Possible side effects, including venous thrombus and infection, will be investigated and compared between the two groups. Timepoint: The amount of hemoglobin and hematocrit will be measured before surgery and 24 hours after surgery and will be compared with the value measured before the study. Method of measurement: Based on similar results by Jannes et al., it was shown that the use of tranexamic acid reduced the average bleeding by 0.86 ml/cm2 compared to the control group. Considering the results of this study to calculate the minimum required sample size and using the formula to calculate the average difference of bleeding, taking into account the first type error of 5% and the study power of 90%, the minimum sample size for each group will be 47 people. In other words, a total of 94 people will be included in the study.The method of information collection and the specifications of the information collection tool:Based on the designed questionnaire, all patient information, including background and demographic information, will be collected through file review and questioning of patients. Information about outcomes will also be recorded. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Esmaielzadeh
Karaj University of Medical Sciences
Outcome results
None listed