HemostasisCANHAEM-RayNCT07788846
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
A study testing Hemocoll® Fibrillar type-I collagen haemostat, Bone wax and Avitene™ Microfibrillar Collagen Hemostat in people with Hemostasis and Surgical Blood Loss, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 3 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostasis, Surgical Blood Loss, Amputation Stump
- What is being tested?
- Hemocoll® Fibrillar type-I collagen haemostat, Bone wax and Avitene™ Microfibrillar Collagen Hemostat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 3 sitesIndia
- Study dates
- 5 Sep 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India3 sites, 3 recruiting
- Recruiting
Sri Devaraj Urs Medical College
Kolār, Karnataka, 563103
Suhas N Gowda, MS, MCh, 8197137462, suhasngowda90@gmail.com
- Recruiting
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448
Naveen Narayan, MS, MCh, 9980023372, naveen_uno1@yahoo.co.in
Chethan Shivannaiah, DNB, 8277520509, drchethans@gmail.com
- Recruiting
Mysore Medical College and Research Institute
Mysuru, Karnataka, 570001
Vijay Kumar, MS, MCh, 7483696940, mathsyadarshinibellur@gmail.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Hemostasis, Surgical Blood Loss, Amputation Stump, Hemorrhage
- Being tested
- Hemocoll® Fibrillar type-I collagen haemostat, Bone wax, Avitene™ Microfibrillar Collagen Hemostat
- 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
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemocoll® Fibrillar type-I collagen haemostatDevice
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 waxDevice
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 HemostatDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemocoll® fibrillar Type-I collagen haemostat | Active comparator | 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. Receives: Device: Hemocoll® Fibrillar type-I collagen haemostat |
| Bone wax | Active comparator | 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. Receives: Device: Bone wax |
| Avitene™ Microfibrillar Collagen Hemostat | Active comparator | 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. Receives: Device: Avitene™ Microfibrillar Collagen Hemostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (10)
Time to complete 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.
Measured: Intraoperative, from intervention application until confirmed haemostasis
Surgeon-rated ease of application 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.
Measured: Immediately after completion of the haemostatic intervention
Haemostasis Grade
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.
Measured: Immediately following the anatomical-level-specific compression period and during the subsequent 60-second observation.
First-Application Success
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.
Measured: Intraoperative.
Rescue Haemostasis
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.
Measured: Intraoperative.
Rebleeding
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.
Measured: Intraoperative.
Quantitative Blood Loss
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.
Measured: Intraoperative.
Preparation Time
Time required to prepare the allocated haemostatic intervention for application.
Measured: Intraoperative.
Application Time
Time required to apply the allocated intervention to the exposed cancellous bone surface.
Measured: Intraoperative.
Total Intervention Time
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.
Measured: Intraoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start5 Sep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HemostasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
- Sponsor type
- University, hospital or other
- Collaborators
- Mysore Medical College and Research Institute, Mysuru, Sri Devaraj Urs Medical College, Kolar
- Responsible party
- Sponsor
- Investigators
- Prema Dhanraj, MS, MCh, Study chair, Rajarajeswari Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788846
- Sponsor's protocol ID
- AIMS/IEC/292/2026
- Acronym
- CANHAEM-Ray
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27839931Tibi 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.
PubMed 39845297Narayan 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.
PubMed 39649230Narayan 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.
PubMed 41122365Cziperle 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.
PubMed 34104007Uranues 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.
PubMed 35965336Zhou 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.
PubMed 31194062Orgill 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.
PubMed 9468043Hill 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.
PubMed 23548587Robicsek 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.
PubMed 7212838Narayan 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.
PubMed 40747200Narayan 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.
PubMed 40862036
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07788846
- Acronym / sponsor ID
- CANHAEM-Ray / AIMS/IEC/292/2026
- Conditions
- Hemostasis, Surgical Blood Loss, Amputation Stump, Hemorrhage
- Keywords
- cancellous bone bleeding, bone wax, fibrillar type-I collagen, topical hemostatic agent, ray amputation, metatarsal, metacarpal, phalanx
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Adichunchanagiri Institute of Medical Sciences, B G NagaraUniversity, hospital or other
- Collaborators
- Mysore Medical College and Research Institute, Mysuru, Sri Devaraj Urs Medical College, Kolar
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Hemocoll® fibrillar Type-I collagen haemostat | Active comparator | Device: Hemocoll® Fibrillar type-I collagen haemostatParticipants 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. |
| Bone wax | Active comparator | Device: Bone waxParticipants 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. |
| Avitene™ Microfibrillar Collagen Hemostat | Active comparator | Device: Avitene™ Microfibrillar Collagen HemostatParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemocoll® Fibrillar type-I collagen haemostatSterile 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. | Device | Hemocoll® fibrillar Type-I collagen haemostat |
| Bone waxSterile 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. | Device | Bone wax |
| Avitene™ Microfibrillar Collagen HemostatAbsorbable 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. | Device | Avitene™ Microfibrillar Collagen Hemostat |
Primary outcome
Complete haemostasis at the prespecified anatomical assessment time
Time frame: 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.
10 secondary outcomes
Time to complete haemostasis
Time frame: Intraoperative, from intervention application until confirmed haemostasis
Surgeon-rated ease of application of the haemostatic intervention
Time frame: Immediately after completion of the haemostatic intervention
Haemostasis Grade
Time frame: Immediately following the anatomical-level-specific compression period and during the subsequent 60-second observation.
First-Application Success
Time frame: Intraoperative.
Rescue Haemostasis
Time frame: Intraoperative.
Rebleeding
Time frame: Intraoperative.
Quantitative Blood Loss
Time frame: Intraoperative.
Preparation Time
Time frame: Intraoperative.
Application Time
Time frame: Intraoperative.
Total Intervention Time
Time frame: Intraoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 27839931Lewis 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.
- Background: PubMed 39845297Tibi 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.
- Background: PubMed 39649230Narayan 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.
- Background: PubMed 41122365Narayan 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.
- Background: PubMed 34104007Cziperle 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.
- Background: PubMed 35965336Uranues 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.
- Background: PubMed 31194062Zhou 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.
- Background: PubMed 9468043Orgill 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.
- Background: PubMed 23548587Hill 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.
- Background: PubMed 7212838Robicsek 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.
- Background: PubMed 40747200Narayan 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.
- Background: PubMed 40862036Narayan 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prema Dhanraj, MS, MCh study chair
Rajarajeswari Medical College and Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemocoll® Fibrillar type-I collagen haemostat, Bone wax and Avitene™ Microfibrillar Collagen Hemostat in people with Hemostasis and Surgical Blood Loss, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naveen Narayan, MS, MCh (9980023372, naveen_uno1@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete haemostasis at the prespecified anatomical assessment time (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788846, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.