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

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.

Inclusion Criteria: * Age ≥18 years. * Planned surgical single-ray amputation involving one or more phalangeal, metacarpal or metatarsal bone segments. * Presence of an exposed cancellous bone surface following planned bone transection. * Ability to undergo the standardized operative protocol. * Ability to provide written informed consent. * Willingness to comply with postoperative follow-up Exclusion Criteria: * Known congenital or acquired bleeding disorder. * Severe uncorrected coagulopathy. * Severe thrombocytopenia considered clinically significant by the treating team. * Active major haemorrhage unrelated to the operative field. * Requirement for major vascular reconstruction during the procedure. * Procedures in which standardized assessment of cancellous bone bleeding is impossible. * Known hypersensitivity to bovine or ovine collagen or to bone wax. * Previous severe adverse reaction to the study haemostatic materials. * Simultaneous multiple unrelated amputation procedures where attribution of bleeding cannot be standardized. * Inability to obtain informed consent. * Any condition considered by the investigator to make participation unsafe or to compromise the integrity of the trial.