Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Control Intervention1: NIL: NIL
Sponsors
Aegis Lifesciences Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. A Patient requiring haemostasis in surgical procedures where control of bleeding by standard surgical techniques is ineffective or impractical. 2. A Patient or their legally designated guardian is willing to sign Informed Consent Form (ICF) 3. A Patient willing to comply with the requirements given in ICF including the requirements for participating till last follow-up. 4. All patients who are not allergic to gelatin.
Exclusion criteria
Exclusion criteria: 1. A Patient currently participating in another clinical study. 2. A Patient having known bleeding disorder (including thrombocytopenia [less than 100,000 platelet count], thrombasthenia, haemophilia, or Von Willebrand disease) 3. A Patient having allergy to porcine gelatin 4. A Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care), or is lactating. 5. A Patient undergoing ophthalmic surgery. 6. A Patient requiring closure of skin incisions by Flogel because it may interfere with the healing of skin edges. 7. A Patient requiring haemostasis in intravascular compartments because of the risk of embolization. 8. A Patient requiring hemostasis in the absence of active blood flow e.g. while the vessel is clamped or bypassed as it may result in risk of intravascular clotting from intravascular injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Haemostasis Rate: Time to Haemostasis (TTH): Time required to achieve haemostasis after application of the FLOGEL 2)Absorption: Determination of absorption of flowable gelatin haemostatic matrix through medical imaging techniques after 4 weeks (28 days) of its implantation.Timepoint: Pre-Operative, Operative Day 0, Day 2, Day 28, Day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of safety • Determination of complications associated with FLOGEL. • Determination of events of re-bleeding (leading to blood-transfusion) or re-operation after achieving haemostasis. Device Handling Characteristics:Determination of handling characteristics of flowable gelatin haemostatic matrix during its implantation. Timepoint: Pre-Operative, Operative Day 0, Day 2, Day 28, Day 60. | — |
Countries
India
Contacts
Public ContactMr Piyush Patel
Aegis Lifesciences Private Limited
Outcome results
None listed