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Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
Summary
This is a multicentre, prospective, three-arm, parallel-group randomized controlled superiority trial evaluating fibrillar Type-I collagen haemostat (Hemocoll®) FTC, Avitene™ Microfibrillar Collagen Hemostat (MCH), and conventional bone wax for control of bleeding from exposed cancellous bone following planned single-ray amputation. Adults undergoing single-ray amputation involving a phalanx, metacarpal or metatarsal will be randomized in a 1:1:1 ratio. The primary comparison is Hemocoll® FTC versus Avitene™ MCH. Complete haemostasis is defined as VIBe Grade 0 sustained continuously for 60 seconds without rescue haemostasis at the prespecified anatomical assessment time: 2 minutes for phalanx, 3 minutes for metacarpal, and 5 minutes for metatarsal. Secondary comparisons include Hemocoll® FTC versus bone wax and Avitene™ MCH versus bone wax.
Official title: A Multicentre, Prospective, Randomized, Controlled, Three-Arm Superiority Trial Comparing Hemocoll® FTC, Avitene™ MCH, and Conventional Bone Wax for Cancellous Bone Bleeding Following Single-Ray Amputation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
135
Start Date
2026-09-05
Completion Date
2027-01
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
Hemocoll® Fibrillar type-I collagen haemostat
Sterile absorbable fibrillar type-I collagen of bovine or ovine origin, a licensed medical device used within its labelled indication for adjunctive surgical haemostasis. Batch source is documented from the certificate of analysis for every lot used and is disclosed in the participant information sheet; participants may decline participation on that basis without any effect on their care. Assigned to: Fibrillar type-I collagen arm.
Bone wax
Sterile non-resorbable beeswax and isopropyl palmitate blend, a licensed medical device used within its labelled indication for mechanical tamponade of bleeding bone surfaces. Assigned to: Bone wax arm.
Avitene™ Microfibrillar Collagen Hemostat
Absorbable bovine microfibrillar collagen haemostatic material applied directly to the bleeding cancellous bone surface according to the manufacturer instructions for use and study SOP. Applied dry and firmly packed into the spongy bone surface.
Locations (3)
Sri Devaraj Urs Medical College
Kolār, Karnataka, India
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, India
Mysore Medical College and Research Institute
Mysuru, Karnataka, India