Health Condition 1: null- Traumatic bleeding due to scalp injury
Conditions
Interventions
Intervention1: Axiostat®: Size: 8 x 5 cm
Haemostatic dressing.
Axiostat® is a sterile, non-absorbable haemostatic dressing intended to control profuse bleeding within minutes of application by provi
Sponsors
Axio Biosolutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) Age greater than or equal to 18 years. (2) Patient and/or patientâ??s legal representative and/or impartial witness have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IEC of MIMS, Kerala, India. (3)Patients with bleeding wounds over scalp which can due to any injury. The wounds must be bleeding at the time of baseline assessment/randomization. (4) The targeted wound size should be such that it should be covered by single available size of the study device as per the instructions for use.
Exclusion criteria
Exclusion criteria: The exclusion criteria for the study involved prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia). A non-survivable injury as per the investigatorsâ?? discretion. Patients who in the opinion of the investigator may not complete the study for any reason, e.g. Patients requiring immediate suturing. Grossly infected wounds that may reasonably be expected to require multiple debridement procedures prior to clearance of bacteria and non-viable tissue from the wound, in case of old wound. Patient is currently participating in an investigational drug or device study that has not yet completed its primary endpoint or interferes with procedure and assessments in this trial. Patients with Surgical/iatrogenic wound. Patients with a major head injury, spinal injury, neck injury, abdominal injury, deep wound injury, fracture, hemorrhagic shock, foreign materials inside the wound like stab injury.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety & Efficacy (1)Time to achieve haemostasis (2)Number of patients with rebleedingTimepoint: 1 Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Type of injury & location of injuryTimepoint: 1 Day | — |
Countries
India
Contacts
Public ContactShailee Mehta
Axio Biosolutions
Outcome results
None listed