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Clinical Trials/CTRI/2022/03/041192
CTRI/2022/03/041192
Completed
Phase 4

A prospective, single blind, randomized study comparing clinical equivalence of Truwax® (Healthium) and Ethicon® bone wax (Johnson & Johnson) for sternal wound hemostasis in subjects undergoing surgical procedures by sternotomy

Healthium Medtech Limited0 sites92 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Healthium Medtech Limited
Enrollment
92
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female subject aged 18\-70 years, scheduled for sternotomy, for surgical procedures on heart, great vessels and mediastinal lesions
  • •2\. Subject who has given written informed consent

Exclusion Criteria

  • •1\. Subject with a history of median sternotomy
  • •2\. Subject not requiring usage of Bonewax to stop bleeding from the bone exposed by the sternotomy
  • •3\. ASA\-V classified subject
  • •4\. Subject having active infection at or around the skin incision site
  • •5\. Subject with HbA1c more than 10
  • •6\. Subject who is pregnant or lactating
  • •7\. Subject with history of allergy to bee wax or similar products
  • •8\. Subject with history of bleeding disorders
  • •9\. Subject who is already participating in another cardiovascular or similar study or have received an experimental drug or have used an experimental medical device within 30 days prior to the planned start of procedure
  • •10\. Subject unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator

Outcomes

Primary Outcomes

Not specified

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