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

NCT07788846 | Not Yet Recruiting

• 1 other identifier: AIMS/IEC/292/2026
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

cancellous bone; bone wax; fibrillar collagen; topical hemostatic agent; ray amputation; metatarsal; metacarpal; phalanx; intraoperative bleeding; ease of application; surgical handling; VIBe scale

Outcome Measures

Primary Outcomes (1)

• Complete haemostasis of the exposed cancellous bone surface

  Proportion of participants achieving complete haemostasis of the exposed cancellous bone surface following completion of the allocated haemostatic intervention and the prespecified anatomical-level-specific standardized compression period, with no visible bleeding or oozing during the subsequent standardized 60-second observation period and no requirement for additional haemostatic material, cautery, ligation or mechanical intervention during the assessment. The standardized compression period will be determined by the anatomical level and will be identical across all three randomized treatment arms: Phalanx = 2-minute compression; Metacarpal = 3-minute compression; Metatarsal = 5-minute compression.

  Immediately after completion of the anatomical-level-specific compression period, followed by a standardized 60-second observation period (intraoperative)

Secondary Outcomes (10)

• Time to complete haemostasis

  Intraoperative, from intervention application until confirmed haemostasis

• Surgeon-rated ease of application of the haemostatic intervention

  Immediately after completion of the haemostatic intervention

• Haemostasis Grade

  Immediately following the anatomical-level-specific compression period and during the subsequent 60-second observation.

• First-Application Success

  Intraoperative.

• Rescue Haemostasis

  Intraoperative.

Other Outcomes (7)

• Postoperative bleeding

  Postoperative Day 0 and Postoperative Day 7

• Clinically significant postoperative haematoma

  Postoperative Day 1 and Postoperative Day 7

• Surgical-site infection

  Postoperative Day 7 through 6 weeks

Study Arms (3)

Fibrillar type-I collagen

ACTIVE COMPARATOR

Participants randomized to this arm will receive fibrillar Type-I collagen haemostat (Hemocoll®) applied directly over the exposed cancellous bone surface following completion of the amputation, tourniquet release and standardized soft-tissue haemostasis. The material will be applied according to the manufacturer's instructions and study SOP. A standardized sterile non-adherent interface and compression dressing will then be applied.

Device: Fibrillar type-I collagen haemostat

Bone wax

ACTIVE COMPARATOR

Participants randomized to this arm will receive sterile conventional bone wax applied directly to the exposed cancellous bone surface following completion of the amputation, tourniquet release and standardized soft-tissue haemostasis. The amount used will be standardized according to the study SOP and recorded. A standardized sterile non-adherent interface and compression dressing will then be applied.

Device: Bone wax

Standardised compression alone

ACTIVE COMPARATOR

Participants randomized to this arm will receive no topical haemostatic material. A standardized sterile non-adherent interface followed by the standardized compression dressing will be applied directly over the exposed cancellous bone surface. This arm represents mechanical tamponade without a topical haemostatic agent.

Other: Standardised compression protocol

Interventions

Fibrillar type-I collagen haemostat DEVICE

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.

Fibrillar type-I collagen

Bone wax DEVICE

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.

Bone wax

Standardised compression protocol OTHER

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.

Standardised compression alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Naveen Narayan MS, MCh (Plastic Surgery): lead
• Mysore Medical College and Research Institute, Mysuru: collaborator

Study Sites (2)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

Location

Mysore Medical College and Research Institute

Mysuru, Karnataka, 570001, India

Location

Related Publications (12)

• Lewis KM, Li Q, Jones DS, Corrales JD, Du H, Spiess PE, Lo Menzo E, DeAnda A Jr. Development and validation of an intraoperative bleeding severity scale for use in clinical studies of hemostatic agents. Surgery. 2017 Mar;161(3):771-781. doi: 10.1016/j.surg.2016.09.022. Epub 2016 Nov 10.

  PMID: 27839931 BACKGROUND

• Tibi PR, DeAnda A Jr, Leung SK, Huang AP, Siebert T, Dierks SM, Sciubba DM. Global observational survey verifying surgeon utilization of the Validated Intraoperative Bleeding (VIBe) scale for use in clinical practice. Surg Pract Sci. 2022 Aug 28;12:100123. doi: 10.1016/j.sipas.2022.100123. eCollection 2023 Mar.

  PMID: 39845297 BACKGROUND

• Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.

  PMID: 39649230 BACKGROUND

• Narayan N, Shivaiah R, Kumar V, Kumar KM, Chethan S, Gowda S. Comparative Efficacy of High Purity Type I Collagen-Based Skin Substitute and Dehydrated Human Amnion/Chorion Membrane in Diabetic Foot Ulcers: A Multicentre Randomized Controlled Trial. Cureus. 2025 Oct 19;17(10):e94952. doi: 10.7759/cureus.94952. eCollection 2025 Oct.

  PMID: 41122365 BACKGROUND

• Cziperle DJ. Avitene Microfibrillar Collagen Hemostat for Adjunctive Hemostasis in Surgical Procedures: A Systematic Literature Review. Med Devices (Auckl). 2021 Jun 1;14:155-163. doi: 10.2147/MDER.S298207. eCollection 2021.

  PMID: 34104007 BACKGROUND

• Uranues S, Fingerhut A, Levin E, Spazierer D, Rahimi N, Baumgartner B. Effectiveness of Hemopatch(R) versus Surgicel(R) Original to control mild and moderate liver bleeding. BMC Surg. 2022 Aug 14;22(1):316. doi: 10.1186/s12893-022-01747-0.

  PMID: 35965336 BACKGROUND

• Zhou H, Ge J, Bai Y, Liang C, Yang L. Translation of bone wax and its substitutes: History, clinical status and future directions. J Orthop Translat. 2019 Apr 11;17:64-72. doi: 10.1016/j.jot.2019.03.005. eCollection 2019 Apr.

  PMID: 31194062 BACKGROUND

• Orgill DP, Ehret FW, Regan JF, Glowacki J, Mulliken JB. Polyethylene glycol/microfibrillar collagen composite as a new resorbable hemostatic bone wax. J Biomed Mater Res. 1998 Mar 5;39(3):358-63. doi: 10.1002/(sici)1097-4636(19980305)39:33.0.co;2-i.

  PMID: 9468043 BACKGROUND

• Hill J, Little J, Ford T. Bone wax: a foreign body/giant cell reaction in the foot. Foot Ankle Spec. 2013 Jun;6(3):236-8. doi: 10.1177/1938640013484797. Epub 2013 Apr 2.

  PMID: 23548587 BACKGROUND

• Robicsek F, Masters TN, Littman L, Born GV. The embolization of bone wax from sternotomy incisions. Ann Thorac Surg. 1981 Apr;31(4):357-9. doi: 10.1016/s0003-4975(10)60967-8.

  PMID: 7212838 BACKGROUND

• Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul.

  PMID: 40747200 BACKGROUND

• Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug.

  PMID: 40862036 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical; Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Prema Dhanraj, MS, MCh

  Rajarajeswari Medical College and Hospital

  STUDY CHAIR

Central Study Contacts

Naveen Narayan, MS, MCh

CONTACT

9980023372; naveen_uno1@yahoo.co.in

Chethan Shivannaiah, DNB

CONTACT

8277520509; drchethans@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The operating surgeon cannot be blinded because the physical characteristics of the interventions differ. Outcome assessment will be blinded wherever practically possible, and postoperative wound assessment and statistical analysis will be performed using blinded/coded treatment groups where feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery

Model Details: Three-arm, parallel-group randomized controlled trial with participants allocated in a 1:1:1 ratio to fibrillar type-I collagen, conventional bone wax, or standardized compression alone.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months after publication of the primary results and ending 5 years thereafter
• Access Criteria: Methodologically sound proposals whose stated purpose is consistent with the consent given by participants. Identifiable data are retained for \[period per institutional policy\]; de-identified data for a minimum of five years after publication.

Locations

IN (2)