NCT07788846 Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
| NCT ID | NCT07788846 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Adichunchanagiri Institute of Medical Sciences, B G Nagara |
| Condition | Hemostasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2026-09-05 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2026-09-05 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Prema Dhanraj, MS, MCh
STUDY CHAIR
Rajarajeswari Medical College and Hospital
Frequently Asked Questions
Who can join the NCT07788846 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemostasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07788846 currently recruiting?
Yes, NCT07788846 is actively recruiting participants. Contact the research team at naveen_uno1@yahoo.co.in for enrollment information.
Where is the NCT07788846 trial being conducted?
This trial is being conducted at Kolār, India, Mandya, India, Mysuru, India.
Who is sponsoring the NCT07788846 clinical trial?
NCT07788846 is sponsored by Adichunchanagiri Institute of Medical Sciences, B G Nagara. The principal investigator is Prema Dhanraj, MS, MCh at Rajarajeswari Medical College and Hospital. The trial plans to enroll 135 participants.