Amputation Stump, Hemorrhage, Hemostasis, Surgical Blood Loss
Conditions
Keywords
cancellous bone bleeding, bone wax, fibrillar type-I collagen, topical hemostatic agent, ray amputation, metatarsal, metacarpal, phalanx, intraoperative bleeding, ease of application, surgical handling, VIBe scale
Brief summary
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.
Detailed description
This is a multicentre, prospective, randomized, controlled, three-arm, parallel-group superiority trial comparing fibrillar Type-I collagen haemostat (Hemocoll® FTC), Avitene™ Microfibrillar Collagen Hemostat (MCH), and conventional sterile bone wax for control of cancellous bone bleeding following planned single-ray amputation. The study will be conducted at three tertiary-care centres in Karnataka, India, with 135 participants planned and 45 participants per treatment arm. Adults undergoing planned single-ray amputation involving a phalanx, metacarpal or metatarsal with active bleeding from an exposed cancellous bone surface after tourniquet release and completion of soft-tissue haemostasis will be eligible. Participants will be randomized centrally in a 1:1:1 ratio with stratification by anatomical category and baseline VIBe bleeding grade. Participants will receive Hemocoll® FTC, Avitene™ MCH, or conventional bone wax according to the randomized allocation. A common standardized localized compression procedure will be used across all three groups. A single sterile dry gauze layer and standardized compression pad will be secured using a 5-cm-wide elastic crepe bandage calibrated to a target 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 without disturbing the treated surface. The primary endpoint will be assessed at an anatomical-level-specific time measured from completion of application of the allocated haemostatic material: 2 minutes for phalanx, 3 minutes for metacarpal, and 5 minutes for metatarsal. At the scheduled assessment, the compression interface will be removed and the cancellous surface observed continuously for 60 seconds. Complete haemostasis requires VIBe Grade 0 throughout the entire observation period without rescue haemostasis before the assessment. Participants who do not achieve complete haemostasis at the primary assessment will undergo continued standardized treatment and assessment up to a cumulative 10-minute period unless rescue haemostasis is clinically required. Secondary outcomes include final haemostasis, time to haemostasis, first-application success, rescue haemostasis, rebleeding, quantitative blood loss, intervention preparation and application time, total intervention time, material utilization, surgeon-rated ease of application, postoperative bleeding, haematoma, wound complications, material-related adverse events and reoperation.
Interventions
DEVICEHemocoll® Fibrillar type-I collagen haemostat
Sterile 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.
DEVICEBone wax
Sterile 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.
DEVICEAvitene™ Microfibrillar Collagen Hemostat
Absorbable 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.
Sponsors
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Mysore Medical College and Research Institute, Mysuru
Sri Devaraj Urs Medical College, Kolar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The operating surgeon cannot be blinded because the physical characteristics of the interventions differ. Outcome assessment will be blinded wherever practically possible, and postoperative wound assessment and statistical analysis will be performed using blinded/coded treatment groups where feasible.
Intervention model description
Multicentre prospective randomized controlled superiority trial with three parallel treatment groups allocated in a 1:1:1 ratio. The primary confirmatory comparison is Hemocoll® FTC versus Avitene™ Microfibrillar Collagen Hemostat. Hemocoll® versus bone wax and Avitene™ MCH versus bone wax are prespecified secondary comparisons. Randomization is stratified by anatomical category (phalanx, metacarpal, metatarsal) and baseline VIBe grade (Grade 1 vs Grade ≥2).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete haemostasis at the prespecified anatomical assessment time | Intraoperative; 2 minutes after intervention application for phalanx, 3 minutes for metacarpal, and 5 minutes for metatarsal, followed by a 60-second continuous observation period. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete haemostasis | Intraoperative, from intervention application until confirmed 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 | Immediately after completion 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 | Immediately following the anatomical-level-specific compression period and during the subsequent 60-second observation. | 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 | Intraoperative. | 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. |
| Rescue Haemostasis | Intraoperative. | Proportion of participants requiring additional haemostatic intervention because complete haemostasis was not achieved following the allocated intervention and the prespecified anatomical-level-specific standardized compression period. Rescue interventions may include additional study material, cautery, ligation, additional compression or other clinically necessary haemostatic intervention. 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. |
| Rebleeding | Intraoperative. | Proportion of participants developing any visible bleeding from the treated cancellous bone surface after initial successful haemostasis and before wound closure. Initial haemostasis will be assessed following the prespecified anatomical-level-specific standardized compression period: Phalanx = 2-minute compression; Metacarpal = 3-minute compression; Metatarsal = 5-minute compression, followed by the standardized 60-second observation period. |
| Quantitative Blood Loss | Intraoperative. | Blood loss associated with the treated cancellous bone surface will be quantified by Gravimetric method. Five pre-weighed swabs weighed to 0.01 g on a calibrated balance before and after the assessment period; 1 g taken as 1 mL. Identical methodology in all arms. 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. |
| Preparation Time | Intraoperative. | Time required to prepare the allocated haemostatic intervention for application. |
| Application Time | Intraoperative. | Time required to apply the allocated intervention to the exposed cancellous bone surface. |
| Total Intervention Time | Intraoperative. | Total time required for preparation and application of the allocated haemostatic intervention, measured using the standardized study timing procedure. The subsequent anatomical-level-specific 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. |
Countries
India
Contacts
CONTACTNaveen Narayan, MS, MCh
CONTACTChethan Shivannaiah, DNB
STUDY_CHAIRPrema Dhanraj, MS, MCh
Rajarajeswari Medical College and Hospital
Outcome results
None listed