A Post Marketing study of VELSEAL to control the bleeding from severely bleeding wounds due to accidents, trauma cases and deep arterial wounds.

Phase 4

Completed

• Conditions: Health Condition 1: T888- Other specified complications of surgical and medical care, not elsewhere classifiedHealth Condition 2: null- Patients who require haemostasis control for traumatic injuries, both venous and arterial bleeds.

• Registration Number: CTRI/2018/03/012373
• Lead Sponsor: Datt Mediproducts Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-09-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 101

Inclusion Criteria

1. Males and females above 18 years of age who require haemostasis control for traumatic injuries, both venous and arterial bleeds.

2. Subjects who can provide informed consent form in writing and medically in a position to undergo consent and screening processes.

3. The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.

Exclusion Criteria

1. Subjects who present with medical emergency, where treatment is more priority than the informed consent process.

2. Subjects who cannot provide informed consent such as unconscious subjects.

3. The subjects who have been treated with other higher treatment for Haemorrhage control such as Tourniquets for more than 2 hours, Blood or platelet-rich-plasma transfusion etc.

4. Subjects with haematocrit less than 38% or haemoglobin less than 10 gm%.

5. Subjects with known haemorrhagic disorders like GI bleeding, Ante partum haemorrhage, metropathia haemorrhagica, history of haematemesis, haematuria, epistaxis etc.

6. Known cases of genetic bleeding disorder.

7. Subjects who have platelet count one thousand or more below the lower normal limit.

8. Subjects with known possible loss of plasma or blood from other areas than wound such as lacerations, uterine bleeding, gastro-intestinal bleeding etc.

9. The subject has an active infection at the surgical site.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of the VELSEAL Device in controlling Hemorrhage from traumatic injuries, both venous and arterial bleeds.Timepoint: within 10 minutes of study device application

Secondary Outcome Measures

Name	Time	Method
Proportion of Population demonstrating failure of Hemorrhage control within 20 minutes after application of the device. <br/ ><br>Proportion of Population demonstrating secondary Hemorrhage after removal of VELSEAL. <br/ ><br>Proportion of Population with fall in haemocrait more than 20% of the baseline in case of surgical wound and 10% in case of the traumatic wound or Episiotomy, where bleeding cannot be attributed to any cause other than the wound-bleeding <br/ ><br>Timepoint: with in four hour of application