RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara • ClinicalTrials.gov ID: NCT07788846

Registry updated: 2026-09-14

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Hemocoll® Fibrillar type-I collagen haemostat (Device)
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.
Bone wax (Device)
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.
Avitene™ Microfibrillar Collagen Hemostat (Device)
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.

Eligibility criteria

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.

Conditions

Hemostasis Surgical Blood Loss Amputation Stump Hemorrhage

Locations

Sri Devaraj Urs Medical College — Kolār, Karnataka, India
Adichunchanagiri Institute of Medical Sciences — Mandya, Karnataka, India
Mysore Medical College and Research Institute — Mysuru, Karnataka, India

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment