AXIOSTAT Hemostatic Dressing Evaluation Study (AHD): Single centre,Randomised,Open-label,Active Controlled clinical study for safety and Efficacy of AXIOSTATÂ® hemostatic dressing compared to Cotton Gauze in patients with external bleeding wound injury. - AHD

Axio Biosolutions Pvt Ltd0 个研究点目标入组 61 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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.

发起方

Axio Biosolutions Pvt Ltd