Health Condition 1: T889- Complication of surgical and medical care, unspecified Health Condition 2: null- Patients with severely bleeding wounds such as accidents, trauma cases, deep arterial wounds and after angiography / angioplasty
Conditions
Interventions
Intervention1: VELSEAL-T: VELSEAL - T is an innovative medical device for severe bleeds and traumatic bleeding. It is consists of Tranexamic Acid, Chitosan, Gelatin and Thrombin. These constituents ar
Sponsors
Datt Mediproducts Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and females above 18 years of age who require haemostasis control for traumatic injuries, both venous and arterial bleeds and after angiography/angioplasty. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the VELSEAL - T Device in controlling Haemorrhage from traumatic injuries, both venous and arterial bleeds and after angiography/ angioplasty.Timepoint: with in 10 minutes of application of Velseal-T | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Proportion of population demonstrating failure of hemorrhage control within 20 minutes after VELSEAL-T application. b. Proportion of population demonstrating secondary hemorrhage after removal of VELSEAL-T. c. Average time taken for control of the bleeding. d. Average weight change of the device material before application and after removal from the wound.Timepoint: 20 minutes for hemorrhage control. upto 4 hours - followup for safety | — |
Countries
India
Contacts
Public ContactDr Archana Kelkar
Datt Mediproducts Private Limited
Outcome results
None listed