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

This is a multicentre, prospective, randomized, controlled, three‐arm, parallel‐groupsuperiority trial comparing fibrillar Type‐I collagen haemostat (Hemocoll® FTC), Avitene™Microfibrillar Collagen Hemostat (MCH), and conventional sterile bone wax for control ofcancellous bone bleeding following planned single‐ray amputation. The study will beconducted at three tertiary‐care centres in Karnataka, India, with 135 participantsplanned and 45 participants per treatment arm.Adults undergoing planned single‐ray amputation involving a phalanx, metacarpal ormetatarsal with active bleeding from an exposed cancellous bone surface after tourniquetrelease and completion of soft‐tissue haemostasis will be eligible. Participants will berandomized centrally in a 1:1:1 ratio with stratification by anatomical category andbaseline VIBe bleeding grade.Participants will receive Hemocoll® FTC, Avitene™ MCH, or conventional bone wax accordingto the randomized allocation. A common standardized localized compression procedure willbe used across all three groups. A single sterile dry gauze layer and standardizedcompression pad will be secured using a 5‐cm‐wide elastic crepe bandage calibrated to atarget interface pressure of 40 mmHg, with an acceptable operational range of 35‐45 mmHg.Compression will be maintained continuously for 60 seconds and then released withoutdisturbing the treated surface.The primary endpoint will be assessed at an anatomical‐level‐specific time measured fromcompletion of application of the allocated haemostatic material: 2 minutes for phalanx, 3minutes for metacarpal, and 5 minutes for metatarsal. At the scheduled assessment, thecompression interface will be removed and the cancellous surface observed continuouslyfor 60 seconds. Complete haemostasis requires VIBe Grade 0 throughout the entireobservation period without rescue haemostasis before the assessment.Participants who do not achieve complete haemostasis at the primary assessment willundergo continued standardized treatment and assessment up to a cumulative 10‐minuteperiod unless rescue haemostasis is clinically required. Secondary outcomes include finalhaemostasis, time to haemostasis, first‐application success, rescue haemostasis,rebleeding, quantitative blood loss, intervention preparation and application time, totalintervention time, material utilization, surgeon‐rated ease of application, postoperativebleeding, haematoma, wound complications, material‐related adverse events andreoperation.