Studying Safety & Efficacy of Axiostat® Dressing in Acute Hemorrhage Due to Trauma-Comparative Study

NCT03035695 | Completed

• 1 other identifier: ABPL/003
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the efficacy and safety to use external haemostatic between Axiostat® (Chitosan haemostatic dressing) and conventional cotton gauze dressing as a pre hospital acute hemorrhagic control in trauma in ambulance settings.

Conditions

Bleeding

Keywords

Trauma; Scalp injuries; Profused Bleeding; Accident

Outcome Measures

Primary Outcomes (1)

• Time to achieve hemostasis

  Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.

  1 Day

Secondary Outcomes (1)

• Number of patients with rebleeding

  1 Day

Study Arms (2)

Axiostat® Size

EXPERIMENTAL

Device: Axiostat® Size: 8 x 5 cm Axiostat® is a sterile, non-absorbable haemostatic dressing intended to control profuse bleeding within minutes of application by providing an active mechanical barrier to the wound site. Mechanism of action is such that Axiostat® is an extremely positive dressing that becomes very sticky in the presence of negatively charged blood and thus seals the wound area.

Device: Axiostat®

Cotton Gauze

ACTIVE COMPARATOR

Cotton Gauze Size: 8 x 5 cm

Device: Cotton Gauze

Interventions

Axiostat® DEVICE

Also known as: Haemostatic dressing

Axiostat® Size

Cotton Gauze DEVICE

Cotton Gauze

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years.
• Patient and/or patient'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.
• Patients with bleeding wounds over scalp which can due to any injury.
• The wounds must be bleeding at the time of baseline assessment.
• 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.

You may not qualify if:

• A non-survivable injury as per the investigators' 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.

Sponsors & Collaborators

• Axio Biosolutions Pvt. Ltd.: lead

Study Sites (1)

Malabar Insitute of Medical Sciences

Calicut, Kerala, 673016, India

Location

MeSH Terms

Conditions

Hemorrhage; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Mohmmad Kabeer

  Malabar Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 30, 2017
• Study Start: May 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 30, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)