Clinical Study of Bone Wax.
Phase 4
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/12/038668
- Lead Sponsor
- Mr Ashish Baran Dhara
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Subjects without informed consent.
Subject requiring rapid osseous regeneration and fusion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this post market clinical study is to assess the clinical performance, safety and acceptability of the Bone Wax. <br/ ><br>End points <br/ ><br>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 <br/ ><br>2) Occurrence of re-bleeding during the operation will be noted. <br/ ><br>3) Wound infection or other complications within 15 days post procedure <br/ ><br>4) Ease of use using Likertâ??s scale (1-5) <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 3 to 4 months <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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