Collagen, Bone Wax or Compression for Cancellous Bone Bleeding After Single-Ray Amputation

Summary

This is a prospective, three-arm, parallel-group randomized controlled clinical trial evaluating fibrillar Type-I collagen haemostat, conventional bone wax, and standardized compression alone for control of bleeding from exposed cancellous bone following single-ray amputation. Adults undergoing single-ray amputation involving the phalanx, metacarpal or metatarsal will be randomized in a 1:1:1 ratio. The primary outcome is complete haemostasis of the exposed cancellous bone surface following the prespecified intervention and anatomical-level-specific standardized compression period, without rescue haemostatic intervention during the subsequent standardized 60-second observation period. Secondary outcomes include time to haemostasis, haemostasis grade, rescue haemostasis, blood loss, rebleeding, surgeon-rated ease of application, intervention handling time, postoperative bleeding and wound outcomes.

Conditions

• Hemostasis
• Surgical Blood Loss
• Amputation Stump
• Hemorrhage

Interventions

DEVICE

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.

DEVICE

Bone wax

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.

OTHER

Standardised compression protocol

Identical in all arms. The standardised sterile non-adherent interface \[specify product and size\] is placed over the cancellous surface and compression is delivered through a standardised dressing construct by a single designated operator using a calibrated force of \[specify\], applied perpendicular to the transected surface. Compression is held undisturbed for 3 minutes, then the dressing is removed for a 60-second observation; if the surface is not Grade 0 the compression is re-applied to 6 minutes and, if necessary, to 10 minutes, with a 60-second observation after each. Timing is by a dedicated digital stopwatch operated by an independent timekeeper, not by the surgeon. Assigned to: all three arms.

Sponsors & Collaborators

• Mysore Medical College and Research Institute, Mysuru

  collaborator UNKNOWN

• Dr Naveen Narayan MS, MCh (Plastic Surgery)

  lead OTHER

Principal Investigators

• Prema Dhanraj, MS, MCh · Rajarajeswari Medical College and Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2027-01-31

Completion

2027-01-31

Countries

• India

Study Locations