An interventional study of Hemocoll® Fibrillar type-I collagen haemostat and Bone wax in Hemostasis, Surgical Blood Loss and Amputation Stump, sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara. Recruiting at 3 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara · Not applicable, Interventional, and Treatment
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.
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.
213 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's planned enrollment of 135 is above the median of 80 across 160 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →Adichunchanagiri Institute of Medical Sciences, B G Nagara is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Clinically significant
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Hemocoll® Fibrillar type-I collagen haemostat
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.
Device: Bone wax
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.
Device: Avitene™ Microfibrillar Collagen Hemostat
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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative.
Preparation Time
Time required to prepare the allocated haemostatic intervention for application.
Time frame: Intraoperative.
Application Time
Time required to apply the allocated intervention to the exposed cancellous bone surface.
Time frame: 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.
Time frame: Intraoperative.
Postoperative bleeding
Proportion of participants demonstrating postoperative blood or serosanguineous soak-through of the surgical dressing. The presence and severity of dressing soak-through will be recorded according to the standardized study assessment.Dressing strike-through graded none / under 25% / 25-50% / over 50% of dressing area.
Time frame: Postoperative Day 0 and Postoperative Day 7
Clinically significant postoperative haematoma
Proportion of participants developing a clinically significant haematoma at the amputation site following surgery. Haematoma will be recorded when clinically evident and its requirement for additional intervention, aspiration, drainage, reoperation or other treatment will be documented.
Time frame: Postoperative Day 1 and Postoperative Day 7
Surgical-site infection
Proportion of participants developing infection of the surgical wound during postoperative follow-up. Clinical evidence of wound infection, including local inflammatory changes, purulent discharge, wound infection requiring antimicrobial therapy and other clinically diagnosed surgical-site infection, will be recorded.
Time frame: Postoperative Day 7 through 6 weeks
Wound dehiscence
Proportion of participants developing partial or complete separation of the surgical wound following single-ray amputation. Any clinically significant wound dehiscence and requirement for additional wound treatment or reoperation will be recorded.
Time frame: Postoperative Day 7 through 6 weeks
Delayed wound healing
Proportion of participants demonstrating delayed healing of the amputation wound during postoperative follow-up, as assessed clinically by the study investigator. Delayed healing will be recorded when the wound has not achieved satisfactory healing by the predefined follow-up assessment.
Time frame: 6 weeks after surgery
Clinically significant local inflammatory or material-related reaction
Proportion of participants developing a clinically significant local inflammatory or material-related reaction at the surgical site, including suspected hypersensitivity, persistent local inflammation or foreign-body reaction attributable to the allocated haemostatic intervention.
Time frame: 2 weeks and 6 weeks after surgery
Reoperation for bleeding or wound complication
Proportion of participants requiring an unplanned return to the operating room because of postoperative bleeding, haematoma, wound infection, wound dehiscence, delayed wound complication or another treatment-related surgical complication.
Time frame: From the index operation through 6 weeks after surgery
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 12 months after publication of the primary results and ending 5 years thereafter
Access criteria: Methodologically sound proposals whose stated purpose is consistent with the consent given by participants. Identifiable data are retained for [period per institutional policy]; de-identified data for a minimum of five years after publication.
Started Sep 2026 (actual). Primary completion is estimated for Jan 2027, 4 months after the start.
Of 31 non-industry interventional studies with no phase under Blood Loss, Surgical, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 4 months is below that.
Counting every sponsor, half of 40 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Adichunchanagiri Institute of Medical Sciences, B G Nagara