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

NCT：NCT07788846 · RECRUITING

NCT IDNCT07788846

狀態RECRUITING

開始日期2026-09-05

SponsorAdichunchanagiri Institute of Medical Sciences, B G Nagara (OTHER)

First posted2026-08-27

Last updated2026-09-14

簡要摘要

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.

官方來源

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