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Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation

Study acronym: CANHAEM-Ray
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Adichunchanagiri Institute of Medical Sciences, B G Nagara

Record History

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  1. Recruitment opened
    • Start date: Sep 2026 to Sep 5, 2026
    • Site details revised at 3 of 3 sites
    v3
  2. Primary endpoint(s) modifiedv2 Show 8 more changesShow less
    • Sponsor changed: Dr Naveen Narayan MS, MCh (Plastic Surgery) to Adichunchanagiri Institute of Medical Sciences, B G Nagara
    • Interventions modified
    • Study sites: 2 to 3
    • Start date: Aug 2026 to Sep 2026
    • Secondary endpoints: details revised at 1 of 10 entries
    • Study description expanded, about 86 words
    • Collaborators: 1 to 2
    • Study title revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07788846
Lead Sponsor Adichunchanagiri Institute of Medical Sciences, B G Nagara
Collaborators: Mysore Medical College and Research Institute, Mysuru, Sri Devaraj Urs Medical College, Kolar
Conditions
(from sponsor)		 Hemostasis, Surgical Blood Loss, Amputation Stump, Hemorrhage
Related terms Blood Loss, Surgical, Hemorrhage
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov