[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653733":3},{"organization":4,"outcomesModule":7,"designInfo":76,"detailedDescription":85,"studyPopulation":81,"armGroups":86,"interventions":103,"overallOfficials":115,"centralContacts":120,"locations":130,"responsibleParty":176,"collaborators":178,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":186,"sex":192,"minAge":193,"maxAge":81,"enrollmentInfo":194,"targetDuration":81,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":206,"overallStatus":133,"whyStopped":81,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},{"fullName":5,"class":6},"Adichunchanagiri Institute of Medical Sciences, B G Nagara","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"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.\n\nThe 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.",[14,18,22,26,30,33,36,39,42,45],{"measure":15,"description":16,"timeFrame":17},"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.","Intraoperative, from intervention application until confirmed haemostasis",{"measure":19,"description":20,"timeFrame":21},"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.","Immediately after completion of the haemostatic intervention",{"measure":23,"description":24,"timeFrame":25},"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.","Immediately following the anatomical-level-specific compression period and during the subsequent 60-second observation.",{"measure":27,"description":28,"timeFrame":29},"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.","Intraoperative.",{"measure":31,"description":32,"timeFrame":29},"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.",{"measure":34,"description":35,"timeFrame":29},"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.",{"measure":37,"description":38,"timeFrame":29},"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.\n\nThe 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.",{"measure":40,"description":41,"timeFrame":29},"Preparation Time","Time required to prepare the allocated haemostatic intervention for application.",{"measure":43,"description":44,"timeFrame":29},"Application Time","Time required to apply the allocated intervention to the exposed cancellous bone surface.",{"measure":46,"description":47,"timeFrame":29},"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.",[49,53,57,61,64,68,72],{"measure":50,"description":51,"timeFrame":52},"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 \u002F under 25% \u002F 25-50% \u002F over 50% of dressing area.","Postoperative Day 0 and Postoperative Day 7",{"measure":54,"description":55,"timeFrame":56},"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.","Postoperative Day 1 and Postoperative Day 7",{"measure":58,"description":59,"timeFrame":60},"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.","Postoperative Day 7 through 6 weeks",{"measure":62,"description":63,"timeFrame":60},"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.",{"measure":65,"description":66,"timeFrame":67},"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.","6 weeks after surgery",{"measure":69,"description":70,"timeFrame":71},"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.","2 weeks and 6 weeks after surgery",{"measure":73,"description":74,"timeFrame":75},"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.","From the index operation through 6 weeks after surgery",{"allocation":77,"interventionModel":78,"interventionModelDescription":79,"primaryPurpose":80,"observationalModel":81,"timePerspective":81,"maskingInfo":82},"RANDOMIZED","PARALLEL","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).","TREATMENT",null,{"masking":83,"maskingDescription":84,"whoMasked":81},"NONE","The operating surgeon cannot be blinded because the physical characteristics of the interventions differ. Outcome assessment will be blinded wherever practically possible, and postoperative wound assessment and statistical analysis will be performed using blinded\u002Fcoded treatment groups where feasible.","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.\n\nAdults 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.\n\nParticipants 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.\n\nThe 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.\n\nParticipants 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.",[87,93,98],{"label":88,"type":89,"description":90,"interventionNames":91},"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.",[92],"Device: Hemocoll® Fibrillar type-I collagen haemostat",{"label":94,"type":89,"description":95,"interventionNames":96},"Bone wax","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.",[97],"Device: Bone wax",{"label":99,"type":89,"description":100,"interventionNames":101},"Avitene™ Microfibrillar Collagen Hemostat","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.",[102],"Device: Avitene™ Microfibrillar Collagen Hemostat",[104,109,112],{"type":105,"name":106,"description":107,"armGroupLabels":108,"otherNames":81},"DEVICE","Hemocoll® 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.",[88],{"type":105,"name":94,"description":110,"armGroupLabels":111,"otherNames":81},"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.",[94],{"type":105,"name":99,"description":113,"armGroupLabels":114,"otherNames":81},"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.",[99],[116],{"name":117,"affiliation":118,"role":119},"Prema Dhanraj, MS, MCh","Rajarajeswari Medical College and Hospital","STUDY_CHAIR",[121,126],{"name":122,"role":123,"phone":124,"phoneExt":81,"email":125},"Naveen Narayan, MS, MCh","CONTACT","9980023372","naveen_uno1@yahoo.co.in",{"name":127,"role":123,"phone":128,"phoneExt":81,"email":129},"Chethan Shivannaiah, DNB","8277520509","drchethans@gmail.com",[131,150,162],{"facility":132,"status":133,"city":134,"state":135,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":144,"contacts":145},"Sri Devaraj Urs Medical College","RECRUITING","Kolār","Karnataka","563103","India","IN",{"type":140,"coordinates":141},"Point",[142,143],78.12999,13.13768,{"lat":143,"lon":142},[146],{"name":147,"role":123,"phone":148,"phoneExt":81,"email":149},"Suhas N Gowda, MS, MCh","8197137462","suhasngowda90@gmail.com",{"facility":151,"status":133,"city":152,"state":135,"zip":153,"country":137,"countryCode":138,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Adichunchanagiri Institute of Medical Sciences","Mandya","571448",{"type":140,"coordinates":155},[156,157],76.89746,12.5223,{"lat":157,"lon":156},[160,161],{"name":122,"role":123,"phone":124,"phoneExt":81,"email":125},{"name":127,"role":123,"phone":128,"phoneExt":81,"email":129},{"facility":163,"status":133,"city":164,"state":135,"zip":165,"country":137,"countryCode":138,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Mysore Medical College and Research Institute","Mysuru","570001",{"type":140,"coordinates":167},[168,169],76.63925,12.29791,{"lat":169,"lon":168},[172],{"name":173,"role":123,"phone":174,"phoneExt":81,"email":175},"Vijay Kumar, MS, MCh","7483696940","mathsyadarshinibellur@gmail.com",{"type":177,"investigatorFullName":81,"investigatorTitle":81,"investigatorAffiliation":81,"oldNameTitle":81,"oldOrganization":81},"SPONSOR",[179,182],{"name":180,"class":181},"Mysore Medical College and Research Institute, Mysuru","UNKNOWN",{"name":183,"class":181},"Sri Devaraj Urs Medical College, Kolar","100653733","collagen-bone-wax-or-compression-for-cancellous-bone-bleeding-after-single-ray-amputation-100653733",false,"NCT07788846","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","CANHAEM-Ray","Inclusion Criteria:\n\n* Age ≥18 years.\n* Planned surgical single-ray amputation involving one or more phalangeal, metacarpal or metatarsal bone segments.\n* Presence of an exposed cancellous bone surface following planned bone transection.\n* Ability to undergo the standardized operative protocol.\n* Ability to provide written informed consent.\n* Willingness to comply with postoperative follow-up\n\nExclusion Criteria:\n\n* Known congenital or acquired bleeding disorder.\n* Severe uncorrected coagulopathy.\n* Severe thrombocytopenia considered clinically significant by the treating team.\n* Active major haemorrhage unrelated to the operative field.\n* Requirement for major vascular reconstruction during the procedure.\n* Procedures in which standardized assessment of cancellous bone bleeding is impossible.\n* Known hypersensitivity to bovine or ovine collagen or to bone wax.\n* Previous severe adverse reaction to the study haemostatic materials.\n* Simultaneous multiple unrelated amputation procedures where attribution of bleeding cannot be standardized.\n* Inability to obtain informed consent.\n* Any condition considered by the investigator to make participation unsafe or to compromise the integrity of the trial.","ALL","18 Years",{"count":195,"type":196},135,"ESTIMATED","INTERVENTIONAL",[199],"NA","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.",[202,203,204,205],"Hemostasis","Surgical Blood Loss","Amputation Stump","Hemorrhage",[207,208,209,210,211,212,213,214,215,216,217,218],"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","2026-09-10",{"date":221,"type":222},"2026-09-14","ACTUAL",{"date":224,"type":196},"2026-09-05",{"date":226,"type":196},"2027-01",{"name":5,"class":6},3]