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Can a collagen sponge stop bone bleeding better than wax?

NCT ID NCT07788846

Disease control Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This trial compares three ways to control bleeding from exposed bone after a ray amputation, a surgery that removes a finger or toe bone. Researchers test a fibrillar collagen haemostat against traditional bone wax and simple compression. Adults undergoing this surgery are randomly assigned to one of the three methods. The main goal is to see which approach most reliably stops bleeding within a set time, without needing extra measures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fibrillar type-I collagen haemostat, a sterile absorbable collagen material applied to the bleeding bone surface to help stop bleeding.
What this could lead to
If it works, this could offer a safer and more effective way to control bone bleeding during amputations, potentially reducing complications and improving recovery.
What could go wrong
This is a relatively small, early-stage trial, and the collagen material may not prove superior to standard methods. There is also a risk of allergic reaction or infection at the surgical site.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 135 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Blood Loss, Surgical Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amputation stump Hemorrhage Hemostasis Surgical blood loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Adichunchanagiri Institute of Medical Sciences

    Mandya, Karnataka, 571448, India

  • Mysore Medical College and Research Institute

    Mysuru, Karnataka, 570001, India

  • Sri Devaraj Urs Medical College

    Kolār, Karnataka, 563103, India

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