RecruitingNot ApplicableNCT07788846

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

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

Sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Enrollment

135 participants

Start Date

Sep 5, 2026

Study Type

INTERVENTIONAL

Conditions

Surgical Blood Loss Hemostasis Hemorrhage Amputation Stump

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Avitene™ Microfibrillar Collagen Hemostat, a medical device called Bone wax, and others for people with amputation stump, hemorrhage, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.