Health Condition 1: T149- Unspecified injury
Conditions
Interventions
Intervention1: AcuClot +
Standard of Care: AcuClot will be applied to the bleeding site,
providing gentle compression until complete
haemostasis is achieved.
Duration of participation: 02 days
Trea
Sponsors
Anziam Bio Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Each patient must meet all of the following criteria to be enrolled in the study: 1. Both Male and Female aged more than and equals to 18 years to less than 65 years. 2. Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to enrollment. 3. Be with Accessible Traumatic Bleedings/Haemorrhage 4. Wound must be bleeding actively at the time of baseline assessment 5. Wound size should be covered by a single available size of study device 6. Subjects willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: Subjects with any of the following conditions will be excluded from the study: 1. Patients who had a prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia); 2. A non-survivable injury as per the investigatorââ?¬•s discretion; 3. Patients who, in the opinion of the investigator, may not complete the study for any reason (e.g., patients requiring immediate suturing); 4. Grossly infected wounds which may require multiple debridement procedures prior to clearance of bacteria; 5. Patients currently participating in an investigational drug or device study that had not yet completed its primary endpoint or interfered with procedure and assessments in this study; 6. Patients with a surgical/iatrogenic wound; 7. Patients with a major head injury, spinal injury, neck injury, abdominal injury, deep wound injury, fracture, hemorrhagic shock, or foreign materials inside the wound, such as a stab injury.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of ââ?¬Å?AcuClot- Biopolymer based Haemostatic Spongeââ?¬? (Anziam Bio Private Limited, Rajasthan India), as a haemorrhage control device in the Out Hospital and In-Hospital Settings.Timepoint: Visit 1 (Day 1 ) and Visit 2 (Day 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the safety of ââ?¬Å?AcuClot- Biopolymer based Haemostatic Spongeââ?¬? (Anziam Bio Private Limited, Rajasthan India), as a haemorrhage control device in the Out-Hospital and In-Hospital Settings.Timepoint: Visit 1 (Day 1 ) and Visit 2 (Day 2) | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Pvt. Ltd
Outcome results
None listed