Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Aegis Lifesciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Used in all except those who are having known allergy to cellulose 2. Patient or their LDR is willing to sign Informed Consent Form (ICF) 3. Patients undergoing following surgeries: Abdominal Surgery, Gynecological Surgery, Partial Nephrectomy, Anorectal Surgery, Hysterectomy, Plastic Surgery, Dental Surgery, Neuro Surgery, Cardiovascular Surgery, ENT surgery, Orthopedic Surgery, Spinal Surgery, Genito Urinary Surgery, Otolaryngological Surgery, Tumor Surgery, Hepatic Surgery, Ophthalmic Surgery, Cardiothoracic Surgery, General Surgery, Obstetrics Surgery, Urologic Surgery. 4. Patient is willing to comply with the requirements given in ICF including the requirements for participating till last follow-up.
Exclusion criteria
Exclusion criteria: 1. Haemostat to be used for packing and wadding without removal after hemostasis is achieved. 2. Haemostat to be used for implantation in bone defects, such as fractures, which may interfere with callus formation and may cause cyst formation. 3. Removal of haemostat is not possible after achieving hemostasis in or around foramina in bone, areas of bony confine, the spinal cord or the optic nerve and chiasm. 4. Hemostasis is required for hemorrhage from large arteries. 5. Treatment non hemorrhagic serious oozing surfaces, since body fluids, except whole blood, such as serum, do not react with Surgi ORC Haemostat to give satisfactory result. 6. Haemostat is required as adhesion prevention product. 7. Patients with known hypersensitivity of Cellulose. 8. Hemostasis is required in open blood vessel. 9. Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care), or is lactating. 10. Patient has an active infection at the surgical site. 11. Patient has known bleeding disorder (including thrombocytopenia [less than 100,000 platelet count], thrombobasthenia, haemophilia, or von Willebrand disease) 12. Patient has received antibiotic solutions or powders at the intended application site. 13. Patient is unavailable for follow-up. 14. Patient is currently participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of Time to Heamostasis (TTH) Time Frame Day 0 Surgery-Proportion of wounds achieving hemostasis at every 2 minutes, 5 minutes and 10 minutes after the application of Surgi-ORC.Timepoint: Pre-Operative, Operative Day 0, Day 2, Day 28, Day 60. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Hemostatic Handling Characteristics Surgeons Questionnaire Time Frame Day 0 Surgery Determination of handling characteristics of Surgi-ORC during its implantation. 2 Liquefication of Surgi-ORC Time Frame Day 2 post-Procedure Determination of initiation of absorption of Surgi-ORC through radiological examination after 2 days of its implantation. 3 Complete Absorption of Surgi-ORC Time Frame Day 28 post-procedure Determination of complete absorption of oxidized regenerated cellulose through radiological examination after 28 days of its implantation. 4 Determination of Safety Time Frame Procedure up to 60 days post-procedure Evaluation of rate of complication adverse reaction due to the implantation of Surgi-ORC.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