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 must be an adult age group, and both men and women are included in the study. 2.Subjects must be treated with MERIFEIM TAMPON Absorbable Gelatin Sponge U.S.P. intraoperative hemostatic device, wherein pressure, ligature, and other conventional procedures are ineffective or impractical for control of capillary, venous, and arteriolar bleeding, are included in the study. 3.Subjects with the absence of any prior surgical interventions at the designated site are included in the study. 4.Subjects with the absence of active bleeding pre-operatively, as determined by clinical symptoms, vital signs, and laboratory examination findings are included in the study. 5.The Subjects must be willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form. If the Subject is not able to write on behalf of the Subject, the Subject`s Legally acceptable representative (LAR) can fill out the informed consent. When a Subject and LAR are illiterate, a literate impartial witness is required during consenting. 6.The Subject is willing and able to comply with post-procedure scheduled clinical and radiographic evaluations.
Exclusion criteria
Exclusion criteria: 1.Subject is unwilling or unable to sign the Informed Consent Document. 2.Subjects undergoing closure of skin incisions because it may interfere with the healing of skin edges. 3.Subject has any known sensitivity or allergy to gelatin or any other AGS component will disqualify a participant from the trial. 4.Subjects with known bleeding disorders (such as hemophilia or thrombocytopenia) or those using anticoagulant therapy who cannot be safely monitored throughout the trial will be excluded from the study. 5.Subjects undergoing treatment to control postpartum hemorrhage or menorrhagia will be excluded. 6.Subjects undergoing treatment in intravascular compartments will be excluded due to the risk of embolization. 7.Subjects treating with methyl methacrylate adhesives, autologous blood salvage circuits, or undergoing primary therapy for coagulation disorders will be excluded. 8.If subject has any infection will be excluded. 9.Subjects with any instance of pumping arterial hemorrhage will be excluded. 10.Subjects undergoing treatment of ophthalmic procedures. 11. Subjects with pooled blood or other fluids, or cases where the point of hemorrhage is submerged, will be excluded, as MERIFEIM TAMPON will not function as a tampon or plug at the bleeding site, nor will it prevent blood from collecting behind a tampon. 12.Pregnant women will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Gelatin Sponge for Hemostasis in Surgical Settings 2.Device-related adverse eventTimepoint: 1.Time Frame: intraoperatively 2.Time Frame: 48 Hours , 15 days, 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Device Success 2.Hemostatic 3.Length of hospital stay 4.Post-operative painTimepoint: 1.Time Frame: intra operative 2.Time Frame: Intra operative 3.Time Frame: From Admission to Discharge 4.Time Frame: Post operative, 48 Hours , 15 days, 30 days | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed