Evaluation of the effect of new polysaccharide homeostasis powder in controlling bleeding
- Conditions
- bleeding.Hemorrhage, not elsewhere classified
- Registration Number
- IRCT20121117011491N3
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 192
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.