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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20121117011491N3
Enrollment
192
Registered
2021-11-12
Start date
2021-11-21
Completion date
Unknown
Last updated
2021-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bleeding. Hemorrhage, not elsewhere classified

Interventions

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 Unive

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Mohammadi

Shiraz University of Medical Sciences

mohammadi@sums.ac.ir+98 71 3623 1557

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026