Bleeding control after single-ray amputation: Hemocoll vs Avitene vs bone wax

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective randomized trial compares three topical hemostatic options for controlling cancellous bone bleeding after tourniquet release in adults undergoing planned single-ray amputation. Participants are randomized 1:1:1 to Hemocoll fibrillar Type-I collagen, Avitene microfibrillar collagen hemostat, or conventional bone wax, with a standardized compression protocol applied to the treated surface. The primary endpoint is complete hemostasis within a time frame specific to the affected bone (phalanx, metacarpal, or metatarsal). Secondary comparisons include Hemocoll versus bone wax and Avitene versus bone wax. The study aims to enroll 135 participants across three tertiary centers in Karnataka, India.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Where it's running

• Sri Devaraj Urs Medical College
  Kolār, Karnataka, India Recruiting
• Adichunchanagiri Institute of Medical Sciences
  Mandya, Karnataka, India Recruiting
• Mysore Medical College and Research Institute
  Mysuru, Karnataka, India Recruiting

Study contacts

• Study coordinator: Naveen Narayan, MS, MCh
• Email: naveen_uno1@yahoo.co.in
• Phone: 9980023372

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.