A clinical trial to study the effects Axiostat® Dressing to stop bleeding from external injury/wound

Phase 4

Completed

• Conditions: Health Condition 1: null- Patients with bleeding wounds in upper and/or lower extremities which can be due to any injury. Wounds must be bleeding at the time of baseline assessment /randomization.

• Registration Number: CTRI/2016/07/007100
• Lead Sponsor: Axio Biosolutions Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 61

Inclusion Criteria

1. Age greater than or equal to 18 years.

2. Patient and/or patientâ??s legal representative and/or impartial witness has/have been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the investigative site.

3. Patients with bleeding wounds in upper and/or lower extremities which can be due to any injury. Wounds must be bleeding at the time of baseline assessment /randomization.

4. The targeted wound size should be such that it is covered by single available size of the study device as per the instructions for use.

Exclusion Criteria

1. Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.)

2. Patients with known sensitivity to chitosan (shellfish) or the gauze dressings used in this study.

3. Non-survivable injury, as per the Investigatorsâ?? discretion.

4. Patients who, in the opinion of the Investigator, may not complete the study for any reason, e.g. Patient requiring immediate suturing.

5. 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.

6. 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, as per the Investigatorsâ?? discretion.

7. Surgical / iatrogenic wound, as per the Investigatorsâ?? discretion.

8. Patients with a major head injury, spinal injury, neck injury and abdominal injury, as per the Investigatorsâ?? discretion.

9. Patients with deep wound injury, as per the Investigatorsâ?? discretion.

10. Patients with foreign materials inside the study wound like stab injury, as per the Investigatorsâ?? discretion.

12. Patients with major fracture, as per the Investigatorsâ?? discretion.

13. Patients with hemorrhagic shock.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: <br/ ><br>Shortest time to hemostasis (The start of treatment application at the target bleeding site to the achievement of hemostasis). <br/ ><br>Safety: <br/ ><br>Occurrence of rebleeding after AXIOSTAT/Cotton Gauze is removed from wound after 30 minutes of achieving hemostasis using saline water. <br/ ><br>Sensitivity to skin like irritation till end of patient follow up.Timepoint: 1 Day

Secondary Outcome Measures

Name	Time	Method
â?¢To assess comfort levels in treating doctors and patients treated with AXIOSTAT dressings as compared to cotton gauze dressings. <br/ ><br>â?¢Requirement for rescue hemostasis or crossover of treatment in case of device failure to achieve hemostasis. <br/ ><br>â?¢% success of hemostasis <br/ ><br>Timepoint: 1 Day