Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Surgical Bone Wax: Bone wax stick with a weight of 2.5 gms .
Frequency of usage is once.
Duration is 2to3 hours.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Mr Ashish Baran Dhara
Eligibility
Inclusion criteria
Inclusion criteria: Subject with Informed consent. Adult patients who are >= 18 years old, have undergone neurosurgery. Subject using Bone Wax to control bleeding from bone surfaces. Subject with known sensitivities or allergies to bees wax, pollen grains, paraffin wax and iso propyl palmitate.
Exclusion criteria
Exclusion criteria: Subjects without informed consent. Subject requiring rapid osseous regeneration and fusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this post market clinical study is to assess the clinical performance, safety and acceptability of the Bone Wax. End points 1) Qualitative determination of bleeding and hemostatic action during application graded by the surgeon using the mild, moderate, and severe for bleeding and complete, moderate, minimal, and failure for hemostatic action 2) Occurrence of re-bleeding during the operation will be noted. 3) Wound infection or other complications within 15 days post procedure 4) Ease of use using Likertâ??s scale (1-5) Timepoint: 3 to 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary Objective is to determine any undesirable events under normal condition of use and identify the presence of any new emergent risks, known and unknown residual risk. The study will focus on identifying possible systematic misuse or off-label use of the device.Timepoint: 3 to 4 months | — |
Countries
India
Contacts
Public ContactDr Murali Mohan S
Sagar Hospitals
Outcome results
None listed