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.
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.
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.
Parallel
Hemocoll® Fibrillar type-I collagen haemostat
DeviceSterile 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
DeviceSterile 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
DeviceAbsorbable 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.
Complete haemostasis at the prespecified anatomical assessment time
Proportion of participants achieving complete haemostasis of the exposed cancellous bone surface at the prespecified anatomical assessment time following application of the randomized haemostatic intervention and applied common standardized compression procedure. The primary assessment occurs at 2 minutes for phalanx, 3 minutes for metacarpal and 5 minutes for metatarsal, measured from completion of application of the allocated haemostatic material. At the scheduled assessment, the compression interface is removed and the treated cancellous surface is observed continuously for 60 seconds. Complete haemostasis is defined as VIBe Grade 0 throughout the entire 60-second observation period, without rescue haemostasis before completion of the assessment.
Time to complete haemostasis
Time from application of the randomized haemostatic intervention until the first point at which complete haemostasis of the exposed cancellous bone surface is achieved. The intervention application time, completion of the prescribed anatomical-level-specific compression period and time of confirmed haemostasis will be recorded separately. The standardized compression period will be identical across treatment arms within each anatomical category: Phalanx = 2-minute compression; Metacarpal = 3-minute compression; Metatarsal = 5-minute compression.
Surgeon-rated ease of application of the haemostatic intervention
Surgeon-rated ease of application will be assessed immediately following completion of the allocated haemostatic intervention using a 0-10 visual analogue scale ranging from 0 (extremely difficult to apply) to 10 (extremely easy to apply). Additional standardized Likert-scale questions will assess ease of preparation, ease of application to the cancellous surface, ability to conform to the bleeding surface, control during application and overall handling.
Haemostasis Grade
Proportion of participants achieving each predefined haemostasis grade (Grade 0, Grade 1, Grade 2 or Grade 3) during the standardized 60-second observation period following completion of the anatomical-level-specific compression period. The standardized compression period will be identical across all three randomized treatment arms within each anatomical category: Phalanx = 2-minute compression; Metacarpal = 3-minute compression; Metatarsal = 5-minute compression.
First-Application Success
Proportion of participants achieving complete haemostasis following the initial application of the allocated haemostatic intervention, without additional haemostatic material or rescue intervention, after completion of the prespecified anatomical-level-specific standardized compression period and subsequent 60-second observation. The compression period will be identical across all three randomized treatment arms within each anatomical category: Phalanx = 2-minute compression; Metacarpal = 3-minute compression; Metatarsal = 5-minute compression.
Postoperative bleeding
Proportion of participants demonstrating postoperative blood or serosanguineous soak-through of the surgical dressing. The presence and severity of dressing soak-through will be recorded according to the standardized study assessment.Dressing strike-through graded none / under 25% / 25-50% / over 50% of dressing area.
Clinically significant postoperative haematoma
Proportion of participants developing a clinically significant haematoma at the amputation site following surgery. Haematoma will be recorded when clinically evident and its requirement for additional intervention, aspiration, drainage, reoperation or other treatment will be documented.
Surgical-site infection
Proportion of participants developing infection of the surgical wound during postoperative follow-up. Clinical evidence of wound infection, including local inflammatory changes, purulent discharge, wound infection requiring antimicrobial therapy and other clinically diagnosed surgical-site infection, will be recorded.
Wound dehiscence
Proportion of participants developing partial or complete separation of the surgical wound following single-ray amputation. Any clinically significant wound dehiscence and requirement for additional wound treatment or reoperation will be recorded.
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Adichunchanagiri Institute of Medical Sciences, B G Nagara
Lead sponsor
Mysore Medical College and Research Institute, Mysuru
Collaborator
Sri Devaraj Urs Medical College, Kolar
Collaborator
