Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Sterile Hemostatic Absorbable Gelatin Sponge IP/USP (Porcine Origin): Sterile Hemostatic Absorbable Gelatin Sponge IP/USP (Porcine Origin), Manufactured From Highly Purified Porcine Gel
Sponsors
Eucare Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male/females of 18 years of age or older indicated for elective surgical procedures in the above referred surgical specialties/categories 2. Patient who can and willing to provide written Informed Consent 3. Patients with life expectancy of at least one year 4. Patients having acceptance for the use of porcine derived products during the surgery Intra-Operative inclusion criteria 5. Patients with mild or moderate bleeding/oozing during elective surgical procedures where control of bleeding is difficult/ineffective or impractical with other conventional procedures. 6. Absence of intraoperative complications other than bleeding which, in the opinion of the investigator, that may interfere with the assessment of efficacy or safety 7. No active or suspected infection at the pre-defined (pre-selected) surgical site/area 8. No intraoperative use of other topical hemostat containing thrombin simultaneously 9. Approximate Target surgical incisional site of no more than 15cm length
Exclusion criteria
Exclusion criteria: 1. Patient with a known allergy to any porcine derived products including porcine gelatin. 2. Patient having a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol 3. Patient who has participated in another clinical study involving another investigational agent within preceding4 weeks of the start of current trial under the protocol EP-SHG-001_19 or planning to participate in another clinical trial during period of the current study. 4. Patient with known coagulation disorders including thrombocytopenia that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator 5. Patient with Activated Partial Thromboplastin Time (aPTT) > 100 seconds during screening 6. Patient with International Normalized Ratio (INR) greater than 2.5 during screening 7. Patient receiving antiplatelet medications within 5 days prior to surgery 8. Patient has a documented severe congenital or acquired Immunodeficiency. 9. Patients having clinically significant coagulation disorders or diseases, with platelet count is less than 10 x 10 to the power 9 /L during screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of Treatment Emergent Adverse Events (TEAEs) 2, Absence of immediate (real-time) surgical site swelling/inflammation 3. Absence of vessel rupture and concurrent increase in bleeding 4. Absence of increase in bleeding levels without additional vessel rupture 5. Absence of additional bleeding (proximal to the original bleeding site/within the surgical field where the product is applied [Time Frame â?? 1week]Timepoint: Visit 2 [Intraoperative visit, Day of Surgery (Day 0)] to Visit 3 [Post-operative follow-up visit (Day 7/as per investigatorâ??s discretion)] | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Time to achieve surgical haemostasis Time to achieve clinically satisfactory haemostasis will be recorded in minutes from the first application of study treatment until cessation of bleeding as indicated by the Investigator. Timepoint: Visit 2 [Intraoperative visit, Day of Surgery (Day 0)] to Visit 3 [Post-operative follow-up visit (Day 7/as per investigatorâ??s discretion)] ;Number of Patients achieved haemostasis without subsequent bleeding during the procedure from the site of applicationTimepoint: Visit 2 [Intraoperative visit, Day of Surgery (Day 0)] to Visit 3 [Post-operative follow-up visit (Day 7/as per investigatorâ??s discretion)];Overall Investigatorâ??s satisfaction scale for Sterile Hemostatic Absorbable Gelatin Sponge IP/USP (represented by the brands as indicated elsewhere in the text)at the end of the treatmentTimepoint: Visit 2 [Intraoperative visit, Day of Surgery (Day 0)] to Visit 3 [Post-operative follow-up visit (Day 7/as per investigatorâ??s discretion)] | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappan
Eucare Pharmaceuticals Private Limited
Outcome results
None listed