Immunological safety evaluation of a haemostatic agent and wound dressing made of horse collagen fibrils.
Abstract: A haemostatic agent and wound dressing made of horse collagen (Tachotop) was applied to guinea-pigs in such a way that the intended use of this material in humans was simulated, and cell-mediated and humoral immune responses of the animals were investigated. In addition, immune reactions were forcefully induced in guinea-pigs in order to validate the methodical approach and quantitate the observed reactions. Cell-mediated immunity was measured as delayed-type hypersensitivity skin reactions, and antibodies were detected by an enzyme-linked immunosorbent assay (ELISA). Simulation of the intended application of this haemostyptic material did not induce immune reactions in guinea-pigs even under critical conditions. The animals could only be immunized when the antigen was administered in solution or finely dispersed and together with adjuvant. Immune reactions thus induced were specific for collagen, no reaction was obtained against possible impurities such as albumin, immunoglobulin or fibronectin. It is concluded--in accordance with clinical experience--that this material is very unlikely to induce immune reactions upon clinical application to humans.
Publication Date: 1987-07-01 PubMed ID: 3675675
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- Journal Article
Summary
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This research study evaluated the immunological safety of a haemostatic agent and wound dressing made of horse collagen, concluding that the material is highly unlikely to cause immune reactions upon application to human wounds.
Objective and Methodology of the Research
- The objective of this research was to evaluate the immunological safety of a haemostatic agent and wound dressing named Tachotop, created from horse collagen.
- The tests were carried out on guinea-pigs, simulating the intended use of this material in humans to understand its impact on cell-mediated and humoral immune responses of the animals.
- To validate the testing approach and quantify the observed reactions, immune reactions were forcefully induced in the guinea pigs.
- The researchers evaluated cell-mediated immunity by measuring delayed-type hypersensitivity skin reactions. They also identified antibodies using an enzyme-linked immunosorbent assay (ELISA).
Results of the Research
- Applying the haemostatic agent didn’t induce immune reactions in guinea-pigs, even under critical conditions.
- Immune reactions only occurred when the antigen (the substance which induces an immune response) was administered in a solution or finely dispersed form, along with an adjuvant (substance that enhances the body’s immune response to an antigen).
- The induced immune reactions were specific to collagen, with no reactions observed against possible impurities such as albumin, immunoglobulin or fibronectin. This indicates that any potential immune response would not be triggered by these substances, but specifically by collagen.
Conclusion of the Research
- Based on these tests – which mimic the way the material would be used in a clinical setting – the researchers concluded that this haemostatic agent and wound dressing made of horse collagen is very unlikely to cause immune reactions when used on humans.
- Such a finding is in line with clinical experience, reinforcing the notion that this material is safe for use in wound dressing applications in humans.
Cite This Article
APA
Adelmann-Grill BC, Otto K.
(1987).
Immunological safety evaluation of a haemostatic agent and wound dressing made of horse collagen fibrils.
Arzneimittelforschung, 37(7), 802-805.
Publication
Researcher Affiliations
- Max-Planck-Institut für Biochemie, Martinsried, Fed. Rep. of Germany.
MeSH Terms
- Animals
- Antibody Formation
- Bandages / adverse effects
- Biological Dressings / adverse effects
- Collagen / adverse effects
- Collagen / immunology
- Enzyme-Linked Immunosorbent Assay
- Guinea Pigs
- Hemostatics / adverse effects
- Horses
- Immunity, Cellular / drug effects
- Male
Citations
This article has been cited 5 times.- Gallo N, Natali ML, Curci C, Picerno A, Gallone A, Vulpi M, Vitarelli A, Ditonno P, Cascione M, Sallustio F, Rinaldi R, Sannino A, Salvatore L. Analysis of the Physico-Chemical, Mechanical and Biological Properties of Crosslinked Type-I Collagen from Horse Tendon: Towards the Development of Ideal Scaffolding Material for Urethral Regeneration. Materials (Basel) 2021 Dec 12;14(24).
- Salvatore L, Gallo N, Natali ML, Terzi A, Sannino A, Madaghiele M. Mimicking the Hierarchical Organization of Natural Collagen: Toward the Development of Ideal Scaffolding Material for Tissue Regeneration. Front Bioeng Biotechnol 2021;9:644595.
- Gallo N, Natali ML, Sannino A, Salvatore L. An Overview of the Use of Equine Collagen as Emerging Material for Biomedical Applications. J Funct Biomater 2020 Nov 1;11(4).
- Birth M, Figueras J, Bernardini S, Troen T, Günther K, Mirza D, Mortensen FV. Collagen fleece-bound fibrin sealant is not associated with an increased risk of thromboembolic events or major bleeding after its use for haemostasis in surgery: a prospective multicentre surveillance study. Patient Saf Surg 2009 Jun 22;3(1):13.
- Nistor RF, Chiari FM, Maier H, Hehl K. The fixed combination of collagen with components of fibrin adhesive-a new hemostypic agent in skull base procedures. Skull Base Surg 1997;7(1):23-30.
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