Study of Collagen-Based Thrombin Hemostat for the Control of Bleeding in Spinal Surgery

NCT07354178 | Completed

• 1 other identifier: DRT-CS01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial evaluates the effectiveness and safety of a collagen-based hemostatic agent containing thrombin in patients undergoing spinal surgery. The study compares this investigational product with an existing hemostatic agent to assess whether it performs equally well in controlling surgical bleeding. Patients with spinal stenosis, tumors, or trauma who require spinal surgery will be enrolled. The hemostat will be applied intraoperatively when grade 3 bleeding is observed. The study aims to determine how well the product works in achieving hemostasis and its safety when it is used during surgery.

Conditions

Spinal Tumor; Spinal Injury; Hemostasis; Spinal Stenosis; Spinal Surgery; Intraoperative Bleeding

Outcome Measures

Primary Outcomes (1)

• Hemostasis success rate

  After applying the haemostatic agent to the bleeding site, gentle compression is performed using surgical gauze. After lifting the gauze and washing off the excess hemostatic agent, check if hemostasis is maintained

  Hemostasis at the first bleeding site is confirmed at 1 minute, 2 minutes, 3 minutes, 6 minutes, and 10 minutes

Secondary Outcomes (7)

• Time to hemostasis

  Intraoperation

• Number of hemostats used

  Intraoperation

• Length of Hospital Stay

  From the date of surgical operation (Visit 2) until the date of hospital discharge, assessed up to 1 week (±3 days) after surgery

• Incidence of adverse events

  From first application of the investigational medical device through end of follow-up (up to 8 weeks post-surgery)

• Drain amount

  3 days after surgery

Study Arms (2)

Study Group

EXPERIMENTAL

Group applied with CollaStat®

Device: Floseal®

Control Group

ACTIVE COMPARATOR

Group applied with Floseal®

Device: CollaStat®

Interventions

CollaStat® DEVICE

Clinical subjects are enrolled after the clinical investigator confirms that there are bleeding sites where hemostasis by normal procedures (compression, suturing, electrosurgical scalpel, etc.) is ineffective or difficult to perform. To arrest intraoperative bleeding, the study group is treated with Dalim Tissen's CollaStat® and compressed with general gauze.

Control Group

Floseal® DEVICE

Clinical subjects are enrolled after the clinical investigator confirms that there are bleeding sites where hemostasis by normal procedures (compression, suturing, electrosurgical scalpel, etc.) is ineffective or difficult to perform. To arrest intraoperative bleeding, the control group is treated with Baxter's Floseal® and compressed with general gauze

Study Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An individual who has voluntarily signed the written consent form for participating in the research as a trial subject
• Patients aged 20 or older
• Patients who are able to participate throughout the entire clinical trial period
• Patient scheduled to have spinal surgery due to spinal stenosis, spinal tumor, injury, etc.
• Patients for whom hemostasis is difficult to achieve using standard procedures
• Patients with grade 3 or higher bleeding \* Grade 4 or 5 bleeding is reduced to grade 3 by normal procedures (compression, sutures, electrosurgical scalpel, etc.).

You may not qualify if:

• Pregnant women or those planning to become pregnant within 1 month after application of the collagen-based hemostat
• Individuals with hypersensitivity to bovine-, porcine-, or animal-derived materials
• Individuals deemed inappropriate for participation by the investigators
• Patients who are using treatments that may affect the test results
• Patients with active infections at the surgical site
• Patients with contraindications to the use of local hemostatic materials

Sponsors & Collaborators

• DALIM TISSEN Co., Ltd.: lead

Study Sites (3)

Gangnam Severance Hospital

Seoul, Gangnam-gu, 06273, South Korea

Location

Yongin Severance Hospital

Yongin-si, Giheung-gu, 16995, South Korea

Location

Severance Hospital, Yonsei University Health Syetem

Seoul, Seodaemun-gu, 03722, South Korea

Location

MeSH Terms

Conditions

Spinal Cord Neoplasms; Spinal Injuries; Spinal Stenosis; Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Back Injuries; Wounds and Injuries; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 21, 2026
• Study Start: October 22, 2024
• Primary Completion: June 19, 2025
• Study Completion: August 18, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

KR (3)