A Multicentre, Prospective, Randomized, Controlled, Three-Arm Superiority Trial Comparing Hemocoll® FTC, Avitene™ MCH, and Conventional Bone Wax for Cancellous Bone Bleeding Following Single-Ray Amputation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 3
- 主要终点
- Complete haemostasis at the prespecified anatomical assessment time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Bone wax
Participants randomized to this arm will receive sterile conventional bone wax applied directly to the exposed cancellous bone surface following completion of the amputation, tourniquet release and standardized soft-tissue haemostasis. The amount used will be standardized according to the study SOP and recorded. A standardized sterile non-adherent interface and compression dressing will then be applied.
干预措施: Bone wax (Device)
Hemocoll® fibrillar Type-I collagen haemostat
Participants randomized to this arm will receive sterile absorbable fibrillar Type-I collagen haemostat (Hemocoll®) applied directly to the exposed cancellous bone surface using dry forceps, following completion of the planned single-ray amputation, tourniquet release and standardized soft-tissue haemostasis. The material will be applied according to the current manufacturer instructions for use and study SOP. A standardized dry gauze interface and localized compression construct will subsequently be applied.
干预措施: Hemocoll® Fibrillar type-I collagen haemostat (Device)
Avitene™ Microfibrillar Collagen Hemostat
Participants randomized to this arm will receive Avitene™ Microfibrillar Collagen Hemostat (MCH), applied dry directly to the exposed cancellous bone surface and firmly packed into the spongy bone surface according to the manufacturer instructions for use and study SOP. Dry forceps and dry gloves will be used. A standardized dry gauze interface and localized compression construct will subsequently be applied. Excess Avitene™ will not be removed before the primary endpoint assessment.
干预措施: Avitene™ Microfibrillar Collagen Hemostat (Device)
结局指标
主要结局
Complete haemostasis at the prespecified anatomical assessment time
时间窗: 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.
次要结局
- Time to complete haemostasis(Intraoperative, from intervention application until confirmed haemostasis)
- Haemostasis Grade(Immediately following the anatomical-level-specific compression period and during the subsequent 60-second observation.)
- First-Application Success(Intraoperative.)
- Rescue Haemostasis(Intraoperative.)
- Rebleeding(Intraoperative.)
- Quantitative Blood Loss(Intraoperative.)
- Preparation Time(Intraoperative.)
- Application Time(Intraoperative.)
- Total Intervention Time(Intraoperative.)
- Surgeon-rated ease of application of the haemostatic intervention(Immediately after completion of the haemostatic intervention)
研究者
Dr Naveen Narayan MS, MCh (Plastic Surgery)
Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery
Adichunchanagiri Institute of Medical Sciences, B G Nagara