Health Condition 1: R58- Hemorrhage, not elsewhere classified
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Axiostat Chitosan Hemostatic
Dressing: Chitosan Haemostatic
Dressing is a sterile,
single-use, non-absorbable
haemostatic dressing made up
of 100% chitosan. Chi
Sponsors
Axio Biosolutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years and above, both male and female. 2. Patients undergoing femoral vascular access procedures requiring local haemostasis. 3. Able to provide informed consent (self or next to kin or legally authorized representative). 4. The targeted bleeding site should be such that it is covered by a single available size of the study device, as per the instructions for use.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity or allergy to any component of the study product or related substances (chitosan). 2.Current participation in another clinical trial that may interfere with this study s endpoints. 3.History of bleeding disorders, known coagulopathies or haemophilia.) that may affect the assessment of hemostatic endpoints. 4.Non-survivable injury, as per the Investigators discretion. 5.Patients who, in the opinion of the Investigator, may not complete the study for any reason. 6.Patients with a major head injury, spinal injury, neck injury and abdominal injury, as per the Investigators discretion. 7.Patients with deep wound injury, as per the Investigators discretion. 8.Patients with foreign materials inside the study wound like Stab injury, Bullet injury or Blast, as per the Investigators discretion. 9.Have grossly infected wounds that may reasonably be expected to require multiple debridement procedures prior to clearance of bacteria and nonviable tissue from the wound, in case of old wounds. 10.Patients with hemorrhagic shock. 11.Patients with major fracture, as per the Investigators discretion. 12.Inability or unwillingness to comply with study procedures, including follow-up visits and documentation. 13.Participants requiring the use of additional hemostatic devices or agents in combination with the study device to achieve hemostasis. 14.Participants who are undergoing treatment involving concomitant use of medications or medical devices specifically intended to enhance or support the function of the study device. 15.Patients with multiple puncture or bleeding sites that may interfere with accurate assessment of haemostasis at a single target site. 16.Pregnant or lactating women will be excluded from participation in the study. 17.Subjects who receive heparin doses greater than 100 IU/Kg or who are deemed ineligible at the investigator s discretion will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints: o Incidence of device-related adverse events, including: - Allergic reaction - Site infection - Hematoma or pseudoaneurysm formation o Complications during or after removal (e.g., skin irritation) Performance Endpoints: o Time to haemostasis o Easy to remove o Rebleeding o Muco-adhesion to the wound/bleeding site.Timepoint: Visit 2 and Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Ease of application and removal in treating doctors and comfort levels in patients treated with Chitosan Haemostatic Dressing compared to the Chitosan Based Hemostatic Dressing Comparator. Requirement for the rescue of haemostasis or crossover of treatment in case of device failure to achieve haemostasis. Percentage success of haemostasis Occurrence of adverse events and complications, along with any additional or newly identified events, and patient reported endpoints (PROs).Timepoint: Visit 2 and Visit 3 | — |
Countries
India
Contacts
Public ContactRutuja Chandrarao
Axio Biosolutions Pvt Ltd
Outcome results
None listed