Trials / Completed
CompletedNCT07153822
Efficacy and Safety of Ionized Atelocollagen Adhesion Barrier (Collabarrier®) in Spine Surgery
The Multi-center, Randomized, Subject/Evaluator Blind, Active-controlled, Non-inferiority Pivotal Clinical Study to Compare the Efficacy and Safety of Collabarrier® With Guardix-sol for the Prevention of Postoperative Adhesion After Operation for Disc Herniation or Spinal Stenosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- DALIM TISSEN Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Collagen-based adhesion barrier | Porcine Atelocollagen (Type I) |
| DEVICE | Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier | Sodium Hyaluronate(HA) + Sodium Carboxymethylcellulose(CMC) |
Timeline
- Start date
- 2022-12-15
- Primary completion
- 2024-01-29
- Completion
- 2024-01-29
- First posted
- 2025-09-04
- Last updated
- 2025-09-22
Locations
6 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT07153822. Inclusion in this directory is not an endorsement.