To study effect of Axiostat dressing to stop external bleeding in patients with wound injury.

Phase 4

Completed

• Conditions: Health Condition 1: null- Traumatic bleeding due to scalp injury

• Registration Number: CTRI/2017/04/008319
• 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: 104

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety & Efficacy <br/ ><br>(1)Time to achieve haemostasis <br/ ><br>(2)Number of patients with rebleedingTimepoint: 1 Day

Secondary Outcome Measures

Name	Time	Method
Type of injury & location of injuryTimepoint: 1 Day