Efficacy and Safety of Ionized Atelocollagen Adhesion Barrier (Collabarrier®) in Spine Surgery

NCT07153822 | Completed

• 1 other identifier: DRT-04
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 6

Brief Summary

This multicenter, randomized, subject- and evaluator-blinded, active-controlled, non-inferiority clinical trial was conducted to evaluate the efficacy and safety of Collabarrier®, a collagen-based adhesion barrier, compared to Guardix-sol in patients undergoing lumbar spine surgery for herniated disc or spinal stenosis. A total of 69 adult patients scheduled for first-time partial laminectomy or discectomy were enrolled and randomly assigned to receive either Collabarrier® or Guardix-sol. The investigational device (Collabarrier®) is a gel-type atelocollagen formulation designed to prevent postoperative adhesions by acting as a physical barrier between the dura mater and surrounding tissues. The primary outcome was the mean MRI Scar Score at 6 weeks postoperatively, assessed by independent evaluators blinded to treatment allocation. Secondary outcomes included patient-reported pain scores using a 100-mm Visual Analog Scale (VAS) for low back and leg pain, and functional limitation assessed using the Oswestry Disability Index (ODI), measured at baseline, 3 weeks, and 6 weeks.

Conditions

Lumbar Spinal Stenosis; Lumbar Disc Herniation; Epidural Fibrosis; Postoperative Adhesion

Outcome Measures

Primary Outcomes (1)

• Mean value of MRI scar score assessed by independent evalutor at 6 weeks after medical device use for clinical trial

  6 weeks after medical device application

Secondary Outcomes (3)

• Mean value of 100-mm Visual Analogue Scale (VAS) for back pain assessed by the subject before and at 3 and 6 weeks after medical device use for clinical trial

  Baseline, 3 weeks, and 6 weeks after medical device application

• Mean value of 100-mm Visual Analogue Scale (VAS) for leg pain assessed by the subject before and at 3 and 6 weeks after medical device use for clinical trial

  Baseline, 3 weeks, and 6 weeks after medical device application

• Mean value of Oswestry Disability Index (ODI) for limitations of daily life assessed by the subject before and at 3 and 6 weeks after medical device use for clinical trial

  Baseline, 3 weeks, and 6 weeks after medical device application

Study Arms (2)

Collabarrier®

EXPERIMENTAL

Device: Collagen-based adhesion barrier

Guardix-sol

ACTIVE COMPARATOR

Device: Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier

Interventions

Collagen-based adhesion barrier DEVICE

Porcine Atelocollagen (Type I)

Also known as: adhesion barrier

Collabarrier®

Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier DEVICE

Sodium Hyaluronate(HA) + Sodium Carboxymethylcellulose(CMC)

Also known as: adhesion barrier

Guardix-sol

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged 19 years or older
• Patients diagnosed with lumbar disc herniation or lumbar spinal stenosis based on radiological evidence (MRI or CT) showing nerve root compression at one of the following single levels: L3-L4, L4-L5, or L5-S1
• Patients scheduled to undergo their first partial laminectomy or discectomy for the above condition
• Patients who meet at least one of the following criteria (A, B, C):
• A. Have undergone a minimum of 4 weeks of prior conservative treatment within the 6 months prior to Visit 1 (e.g., physical therapy, use of anti-inflammatory drugs, or muscle relaxants)
• B. Experience intolerable pain and are judged by the investigator to require surgery for lumbar disc herniation or spinal stenosis
• C. Have significant progression of neurological functional loss
• Patients who voluntarily provide written informed consent and are able to comply with the study procedures and visit schedule

You may not qualify if:

• Patients who shows alergic reaction or has previous stroke to main and other ingredients or components of the medical device for this clinical test
• Patients with a medical history of brittle bone
• Patients with a medical history of fracture in lumbar region or ligament injuries by external injury
• Patients who needs to undergo a spine surgery (osteotomy allowable) in addition to partial laminectomy or percutaneous lumbar discectomy for cure of symptom
• Patients with neurological function disorder on intestine/bladder
• Patients with any of such symptoms as excessive exudation, bleeding, acute edema and infection on the part applied
• Patients with Degenerative spinal disorder (other than disc herniation or spinal stenosis) or scoliosis (Cobb's angle is 15° or bigger)
• Patients with any of lymphatic disease, coagulation disoder and/or coagulant taken
• Patients with uncontrolled diabetes that may affect the surgery or the progress after surgery based on the tester's judgment
• Patients with desmosis or autoimmune disease or who has ever taken malignant tumor treatment within 5 years before this surgery
• Patients who has ever undergone a spine surgery on the part for this surgery
• Patients who has ever taken extradural steroid treatment within 2 weeks before surgery or oral steroid drug within 10 days before surgery
• Patients who has ever taken myelogram or lumbar puncture within 24 hours before screening
• Patients with impaired immunity or clinically significant abnormalities in clinical laboratory tests at screening Patients with immunity deteriorated or who shows clinically significant abnormality in lab test items at the moment of screening
• Patients who present clinically severe impairment in cardiovascular, digestive, respiratory, endocrine, or central nervous system, or have a mental illness that significantly affects the trial

Sponsors & Collaborators

• DALIM TISSEN Co., Ltd.: lead

Study Sites (6)

Ajou University Hospital

Seoul, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

The Catholic University of Korea Eunpyeong St. Mary's Hospital

Seoul, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Location

The Catholic University of Korea St. Vincent's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

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: August 18, 2025
• First Posted: September 4, 2025
• Study Start: December 15, 2022
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

KR (6)