Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Sterile Oxidized Regenerated Cellulose Hemostat (ORCH): Sterile Oxidized Regenerated Cellulose Hemostat (ORCH) for Bleeding Control During Elective Intraoperative Procedures & Traumatic
Sponsors
inDerma Medical Devices
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male/females of 18 years of age or older 2. Patient who can and willing to provide written Informed Consent 3. Patients with life expectancy of at least one year Intra-Operative inclusion criteria 1. Patients with mild or moderate bleeding/oozing during elective surgical procedures where control of bleeding is difficult/ ineffective with conventional procedures. 2. Absence of intra-operative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety 3. No active or suspected infection at the pre-defined surgical site/area 4. No intra-operative use of a topical hemostat containing thrombin 5. Approximate Target Bleeding Site of no more than 15cm length
Exclusion criteria
Exclusion criteria: 1.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 2. Patient has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration 3. Patient with any type of coagulation disorders including thrombocytopenia that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator 4. Patient having has a clinically significant coagulation disorder or disease, platelets less than 10 multiplied by 10 to the power of 9 per L during screening 5. Patient with activated partial thromboplastin time (aPTT) greater than 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of participants with Adverse events 2. Absence of immediate surgical site swelling/ inflammation 3. Absence of vessel rupture and concurrent increase in bleeding 4. Absence of increase in bleeding levels without vessel rupture 5. Absence of additional bleeding (proximal to the original bleeding site/ within the surgical field)Timepoint: 1 week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Mean Time to Hemostasis Time to achieve hemostats is will be recorded in minutes from the first application of study treatment until cessation of bleeding 2. Number of Patients achieved hemostasis without any subsequent follow up bleeding during the procedure from the site of application 3.Overall Investigator’s satisfaction scale for Sterile Oxidized Regenerated Cellulose Hemostat (ORCH) represented by brand names as indicated above at the end of the treatment in terms of ease of application & handling.Timepoint: 1 week | — |
Countries
India
Contacts
Public ContactDT Arasu
inDerma Medical Devices
Outcome results
None listed