Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.The Subject of age 18 and above, irrespective of gender willing to undergo intervention with Merifeim. 2. The Subject is willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form. 3.In the case of a Subject and LAR being illiterate, a literate impartial witness is required during consenting. 4. Subjects with the absence of any prior surgical interventions at the designated site. 5. Subjects with the absence of active bleeding preoperatively, as determined by clinical symptoms, vital signs, and laboratory examination findings. 6. The Subject is willing and able to comply with postoperative scheduled clinical evaluations. 7. Subjects who are able to give voluntary, written informed consent to participate in this PMCF and from whom consent has been obtained
Exclusion criteria
Exclusion criteria: 1. Subjects undergoing closure of skin incisions will be excluded, because it may interfere with the healing of skin edges. 2. Subjects with known allergies to collagen. 3. Subjects undergoing treatment in intravascular compartments will be excluded due to the risk of embolization. 4. If subject have any infected wounds or wounds with an inflammatory secretion. 5. If subject has any infection. 6. Subjects treating with methyl methacrylate adhesives, autologous blood salvage circuits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Time to Hemostasis 2.Device-related Adverse events 3.Success rateTimepoint: 1.Time Frame: Intra-operative 2.Time Frame: Post operative 7days, 15days and 1 month 3.Time Frame: up to 6 minutes post procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Intra-operative Blood Loss 2.Post-operative pain score 3.Length of hospital stay 4.Ease of handlingTimepoint: 1.Time Frame: Intra-operative 2.Time Frame: Post-operative 7 days, 15days & 1 month 3.Time Frame: From admission to discharge 4.Time Frame: Intra-operative | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed