CANHAEM-Ray
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 study identifier
interventional
135
1 country
3
Study Start
September 5, 2026
Actual (reported)Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 24, 2026
Actual (reported)August 27, 2026
Actual (reported)September 5, 2026
Actual (reported)January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
Time to complete haemostasis
Intraoperative, from intervention application until confirmed haemostasis
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.
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.
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.
Sri Devaraj Urs Medical College
Kolār, Karnataka, 563103, India
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448, India
Lewis KM, Li Q, Jones DS, Corrales JD, Du H, Spiess PE, Lo Menzo E, DeAnda A Jr. Development and validation of an intraoperative bleeding severity scale for use in clinical studies of hemostatic agents. Surgery. 2017 Mar;161(3):771-781. doi: 10.1016/j.surg.2016.09.022. Epub 2016 Nov 10.
Tibi PR, DeAnda A Jr, Leung SK, Huang AP, Siebert T, Dierks SM, Sciubba DM. Global observational survey verifying surgeon utilization of the Validated Intraoperative Bleeding (VIBe) scale for use in clinical practice. Surg Pract Sci. 2022 Aug 28;12:100123. doi: 10.1016/j.sipas.2022.100123. eCollection 2023 Mar.
Prema Dhanraj, MS, MCh
Rajarajeswari Medical College and Hospital
First Submitted
August 24, 2026
First Posted
August 27, 2026
Surgeon-rated ease of application of the haemostatic intervention
Immediately after completion of the haemostatic intervention
Haemostasis Grade
Immediately following the anatomical-level-specific compression period and during the subsequent 60-second observation.
First-Application Success
Intraoperative.
Rescue Haemostasis
Intraoperative.
Postoperative bleeding
Postoperative Day 0 and Postoperative Day 7
Clinically significant postoperative haematoma
Postoperative Day 1 and Postoperative Day 7
Surgical-site infection
Postoperative Day 7 through 6 weeks
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.
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.
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.
Contact the study team to confirm eligibility.
Mysore Medical College and Research Institute
Mysuru, Karnataka, 570001, India
Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.
Narayan N, Shivaiah R, Kumar V, Kumar KM, Chethan S, Gowda S. Comparative Efficacy of High Purity Type I Collagen-Based Skin Substitute and Dehydrated Human Amnion/Chorion Membrane in Diabetic Foot Ulcers: A Multicentre Randomized Controlled Trial. Cureus. 2025 Oct 19;17(10):e94952. doi: 10.7759/cureus.94952. eCollection 2025 Oct.
Cziperle DJ. Avitene Microfibrillar Collagen Hemostat for Adjunctive Hemostasis in Surgical Procedures: A Systematic Literature Review. Med Devices (Auckl). 2021 Jun 1;14:155-163. doi: 10.2147/MDER.S298207. eCollection 2021.
Uranues S, Fingerhut A, Levin E, Spazierer D, Rahimi N, Baumgartner B. Effectiveness of Hemopatch(R) versus Surgicel(R) Original to control mild and moderate liver bleeding. BMC Surg. 2022 Aug 14;22(1):316. doi: 10.1186/s12893-022-01747-0.
Zhou H, Ge J, Bai Y, Liang C, Yang L. Translation of bone wax and its substitutes: History, clinical status and future directions. J Orthop Translat. 2019 Apr 11;17:64-72. doi: 10.1016/j.jot.2019.03.005. eCollection 2019 Apr.
Orgill DP, Ehret FW, Regan JF, Glowacki J, Mulliken JB. Polyethylene glycol/microfibrillar collagen composite as a new resorbable hemostatic bone wax. J Biomed Mater Res. 1998 Mar 5;39(3):358-63. doi: 10.1002/(sici)1097-4636(19980305)39:33.0.co;2-i.
Hill J, Little J, Ford T. Bone wax: a foreign body/giant cell reaction in the foot. Foot Ankle Spec. 2013 Jun;6(3):236-8. doi: 10.1177/1938640013484797. Epub 2013 Apr 2.
Robicsek F, Masters TN, Littman L, Born GV. The embolization of bone wax from sternotomy incisions. Ann Thorac Surg. 1981 Apr;31(4):357-9. doi: 10.1016/s0003-4975(10)60967-8.
Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.
Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug.
Study Start
September 5, 2026
Actual (reported)Primary Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
The full de-identified participant-level dataset, the data dictionary and the statistical code will be made available on reasonable request to the corresponding author following publication of the primary results, subject to a signed data-sharing agreement and to approval by the Institutional Ethics Committee.
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Source: ClinicalTrials.gov.
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