A Multi-Center, Prospective, Open label, Single Arm, Post Market Surveillance Study to Evaluate the Safety & Efficacy of Sterile Hemostatic Absorbable Gelatin Sponge IP/USP (Porcine Origin), Manufactured From Highly Purified Porcine Gelatin Material and Represented By The Brand Names GelSpon-PÂ®, SCROFALONÂ® , GALENASPONÂ®, MEDISPONGEÂ®, UrgoSponâ?¢, GELBONDClinically Indicated for The Control of Bleeding During Intraoperative Procedures - EP-SHG-001_19

Eucare Pharmaceuticals Private Limited0 个研究点目标入组 150 人开始时间: 待定最近更新: 2023年1月9日

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•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

•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

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