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

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 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.

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.

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.

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.

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.

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.

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 required to prepare the allocated haemostatic intervention for application.

Time required to apply the allocated intervention to the exposed cancellous bone surface.

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.

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.

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.

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.

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.

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.

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.

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.