COLLABARRIER
Collagen-Based Anti-Adhesion Gel
| Item name | Absorbable Adhesion Barrier (CE approved in June 2020) |
| Indication | Collabarrier is used to prevent or reduce an adhesion formation at surgical regions after surgery. |
| Raw material | Type I Porcine collagen |
| Size | 3ml / 6ml |
| Storage | 2~8 ℃ |
| Shelf life | 2 years from the manufacturing date |
| How to use | 1. Remove irrigation uid and sponges for hemostasis before applying the product. 2. Check whether the bleeding of the wounded area has been completely stopped. 3. Remove the protection cap from the tip of the syringe and connect the catheter provided to the tip of the syringe. 4. Apply the product, covering the entire area to be treated. 5. Discard the unused or remaining volume of the product. |
MECHANISM
01 Formation of Physical Barrier
•Application of Collabarrier into the region suspicious for adhesion.
•High viscosity of Collabarrier
•Mucoadhesive force of Collabarrier
[Ionized Collagen(+) / Cell Membrane(-)]
02 Barrier Fixation by Ionic Bond
• Induction of platelet activation by collagen of
Collabarrier
• Ionic bond between negatively-charged platelet and
positively-charged collagen
03 Anti-adhesion
•Formation of collagen-platelet complex
•Wound protection & Prevention of tissue
04 Wound Healing
•Rapid remodeling of mesothelial cell layer & Wound healing
•Biodegradation and absorption in vivo
PRE CLINICAL STUDY
| Subjects: | Sprague-Dawley Rat |
| Application Site: | Peritoneum |
| Methods: | Full thickness defect was created in peritoneum and serosa of the cecum was abraded using the surgical gauze. Saline(negative control group), a competitive product (positive control group, gel typed adhesion barrier) and Collabarrier (test group) were applied to the defect site. |
| Results: | The degree of adhesion was significantly lower in Collabarrier group among the control groups. There were no adverse effects found such as invasion of inflammatory cells at adjacent tissues and necrosis of adjacent tissues in Collabarrier group. |
▶ Y. S. Chung, et al. The effect of ionized collagen for preventing postoperative adhesion. Journal of Surgical Research. 205:341–34 (2016).
A. Saline
B. Collabarrier
C. Competitive Product
Proportion of animals with adhesions
Adhesion severity
Adhesion area
CLINICAL STUDY – CASE 1
|
Subjects |
116 Patients in Yonsei University Severance Hospital in South Korea. |
|
Application Site |
Thyroid |
|
Methods |
Safety evaluation after the bilateral thyroid dissection and the central cervical lymph node dissection, and non-inferiority evaluation with the control group (a competitive product) |
|
Evaluation |
Scoring of Marshmallow esophagography and the degree of adhesion after 6 weeks from post operation. |
|
Results |
The adhesion was decreased in both groups (Collabarrier and a competitive product). |
Equivalence of adhesion barrier effect
Swallowing discomfort for water
CLINICAL STUDY – CASE 2
|
Subjects |
176 Patients who need intrauterine surgery |
|
Application Site |
Uterine cavity |
|
Methods |
Evaluation of safety and non-inferiority with a competitive product after intrauterine surgery |
|
Evaluation |
Evaluation of adhesion incidence rate, adhesion severity, adhesion area for 4 weeks after intrauterine surgery |
|
Results |
With respect to the adhesion incidence rate, it was verified that Collabarrier was non-inferior to the competitive product. |
Adhesion severity
Adhesion area
