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IRCT20121117011491N3 IRCT 2021-11-12 Shiraz University of Medical Sciences Evaluation of the effect of new polysaccharide homeostasis powder in controlling bleeding The survey of the efficacy of new hemostatic polysaccharide powder to control bleeding in acute traumatic patients 2021-11-21 anticipated 192 Complete https://irct.ir/trial/58971 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The stratified randomization method is used in this study. In order to achieve a balance , blocks with size of 4, 6 and 8 are used. For randomization tools, online sources of random table generation have been used, and the generated tables comply with the following specifications. Here are the specifications used to create this table. Block sizes: 4,6,8 Actual list length: 190 Stratification factors: Site (Liver, Abdomen, Skin) Treatment group: Group A, Group B Allocation concealment will be used for concealment and will only be revealed when the patient is assigned to a patient group in the operating room. This is done using sealed envelopes that cannot be read from the outside; the envelope will be opened by the operating room in charge at the moment of surgery and the patient group will be identified. It is impossible to guess the group based on the envelope number since envelopes are randomly numbered, Blinding description: Due to the use of powder and lack of access to similar powders, double-blinding is not possible. Statisticians are unaware of the groups, but surgeons are. It is discussed with all patients that the powder will be used, but they don't know if it has been used. A patient does not notice that the powder was used during anesthesia because the wounds close as well. The analyst will be unaware of the two groups and analyzes will be conducted in two groups without drug specifications. 2 bleeding. Intervention 1: Intervention group: Control bleeding in wounds with moderate or mild bleeding by modified and sterile polysaccharide powder, produced by Knowledge-based Healda Company and Shiraz University of Medical Sciences, with one to 5 grams depending on the size of the wound beside all common methods that are used to control bleeding. The powder may be used one to three times. The powder is biocompatible and biodegradable and is used in trauma patients in operating rooms under sterile conditions. Intervention 2: Control group: Trauma patients with mild to moderate bleeding wounds use gauze and pressure as a common method of bleeding control to control their bleeding. No placebo was used for these patients. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Hamid Mohammadi
Unit 10, Golfam Building ,Golha av , Moaali Abad av
Shiraz Iran (Islamic Republic of) 7187757184 +98 71 3623 1557 mohammadi@sums.ac.ir Shiraz University of Medical Sciences scientific Hamid Mohammadi
Unit 10, Golfam Building, Golha av, Moaali Abad av
Shiraz Iran (Islamic Republic of) 7187757184 +98 71 3623 1557 mohammadi219@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Accepting and signing the informed consent of the patients' legal guardian to allow the use of the powder produced in controlled conditions for the patient Existence of ulcers with mild to moderate bleeding with stable vital sign Age more than 18 years Liver and Pelvic damage without peritoneal perforation 18 years no limit Both Infectious or contaminated wounds with soil or abdominal contents Peritoneal perforation Diabetes Renal or Liver failure Past medical history of Hypersensitivity (Hospitalization or hypotension due to drug anaphylaxis) Past medical history of Autoimmune or Immunodeficiency disease or disorder Severe Malnutrition Hereditary coagulation disorder or severe coagulation disorders that prevent patients from the operation Gall bladder laceration of rupture uncontrolled shock state R58 Hemorrhage, not elsewhere classified Treatment - Drugs Treatment - Drugs Intervention group: Control bleeding in wounds with moderate or mild bleeding by modified and sterile polysaccharide powder, produced by Knowledge-based Healda Company and Shiraz University of Medical Sciences, with one to 5 grams depending on the size of the wound beside all common methods that are used to control bleeding. The powder may be used one to three times. The powder is biocompatible and biodegradable and is used in trauma patients in operating rooms under sterile conditions. Control group: Trauma patients with mild to moderate bleeding wounds use gauze and pressure as a common method of bleeding control to control their bleeding. No placebo was used for these patients. The rate of successful hemostasis. Timepoint: Record of hemostasis status at 3 and 5 minutes since powder spray time. Method of measurement: Recording the amount of residual bleeding based on the Surface Bleeding Severity Scale at 3 and 5 minutes after powder spraying. Wound bleeding volume before reaching homeostasis. Timepoint: 5 minutes after STARTING THE WOUND EVALUATION. Method of measurement: The number of sterile gauze consumed with more than 50% bleeding. Gross tissue reaction. Timepoint: One to three days after powder application as daily record. Method of measurement: Depending on the severity of the tissue reaction, the wound reaction is graded from one to six. Scoring one means there is no obvious tissue reaction, and scoring six means there is necrosis at the wound site. Data entry forms include this scoring system and the registering user check the appropriate grade. Shiraz University of Medical Sciences Approved 2021-09-06 Research Ethics Committee School of Medicine - Shiraz University of Medical Sciences Setad shiraz Fars Iran (Islamic Republic of)