Biocompatibility evaluation for the developed hydrogel wound dressing – ISO-10993-11 standards – InVitro and InVivo study

Author(s):  
Thanusha Av ◽  
Veena Koul

Abstract Assessment of biocompatibility for the developed wound dressing plays a significant role in translational studies. In the present research work, a wound dressing has been developed using gelatin, hyaluronic acid and chondroitin sulfate using EDC as crosslinker in a specific manner. The characterized hydrogel wound dressing was evaluated for its biocompatibility studies by means of ISO-10993-11 medical device rules and standards. Various parameters like skin sensitization test, acute systemic toxic test, implantation study, intracutaneous reactivity test, in vitro cytotoxicity test and bacterial reverse mutation test, were evaluated and the results demonstrated its safety for the pre-clinical investigation.

2013 ◽  
Vol 658 ◽  
pp. 61-66
Author(s):  
Qing Zong Si ◽  
Xiao Li An ◽  
Yang Li ◽  
Bin Liu ◽  
Jin Qing Wang

In order to prepare bioactive hydroxyapatite (Ca10 (PO4)6(OH) 2, HA) coating with ideal biocompatibility, the surface of titanium alloy was treated with the two kinds of chemical methods, which are the acid-alkali-combination method and Self-polymerization-adhesion of dopamine. After pretreatment, the treated titanium alloy plates were immersed in simulated body fluid (SBF) to form HA coating on their surface. The chemical composition of the coating was analyzed by an X-ray diffraction (XRD) and the morphology was observed by a scanning electron microscope (SEM). After that, the plates were training in vitro cytotoxicity test with MC3T3-E1 osteoblasts. Compared with the results of cell culture, the method of Self- polymerization -adhesion of dopamine showed better cell adhesion and proliferation..


2021 ◽  
Vol 23 (2) ◽  
pp. 77
Author(s):  
Tongfei Cheng ◽  
Jinxing Cao ◽  
Xiaohong Jiang ◽  
M.A. Yarmolenko ◽  
A.A. Rogachev ◽  
...  

In this paper, icaritin film was prepared by low-energy beam electron beam deposition (EBD). The material test showed that the structure and composition of icaritin were not changed after electron beam deposition. Then, the film was sliced and immersed in simulated body fluids, it can be seen that the film was released quickly in the first 7 days. With the extension of soaking time, the release rate gradually slowed down, and the release amount exceeded 90% in about 20 days. In vitro cytotoxicity test showed that the relative cell viability rate of the film was still 92.32±1.30% (p<0.05), indicating that the film possessed excellent cytocompatibility.


Pharmaceutics ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 314 ◽  
Author(s):  
Itxaso Garcia-Orue ◽  
Edorta Santos-Vizcaino ◽  
Alaitz Etxabide ◽  
Jone Uranga ◽  
Ardeshir Bayat ◽  
...  

In the current study, we developed a novel gelatin-based bilayer wound dressing. We used different crosslinking agents to confer unique properties to each layer, obtaining a bioinspired multifunctional hydrofilm suitable for wound healing. First, we produced a resistant and non-degradable upper layer by lactose-mediated crosslinking of gelatin, which provided mechanical support and protection to overall design. For the lower layer, we crosslinked gelatin with citric acid, resulting in a porous matrix with a great swelling ability. In addition, we incorporated chitosan into the lower layer to harness its wound healing ability. FTIR and SEM analyses showed that lactose addition changed the secondary structure of gelatin, leading to a more compact and smoother structure than that obtained with citric acid. The hydrofilm was able to swell 384.2 ± 57.2% of its dry weight while maintaining mechanical integrity. Besides, its water vapour transmission rate was in the range of commercial dressings (1381.5 ± 108.6 g/m2·day). In vitro, cytotoxicity assays revealed excellent biocompatibility. Finally, the hydrofilm was analysed through an ex vivo wound healing assay in human skin. It achieved similar results to the control in terms of biocompatibility and wound healing, showing suitable characteristics to be used as a wound dressing.


2014 ◽  
Vol 44 (8) ◽  
pp. 935-943 ◽  
Author(s):  
Michael Pescheck ◽  
Constanze Dürr ◽  
Luděk Bláha ◽  
Dieter Sell

2017 ◽  
Vol 893 ◽  
pp. 35-42 ◽  
Author(s):  
Rui Ma ◽  
Ling Jun Dai ◽  
Lin Wang ◽  
Yu Dian Song

This study prepares the HA/PEEK gradient composites with special structural design by impregnation method, which eases the contradiction of the HA/PEEK composites between the lack of bioactivity due to low HA contents and the poor mechanical properties due to high HA contents, and effectively improves the bioactivity and mechanical properties of the PEEK-based materials, and then evaluates the biosecurity of HA/PEEK gradient composites. The main functional cell of bone formation—osteoblast is adopted for the co-culture with PEEK, HA/PEEK gradient composites and the leach liquor, and the effects of PEEK and HA/PEEK gradient composites on the proliferative functions of osteoblast are studied by in vitro cytotoxicity test. The results show that no harmful admixtures are produced in the process of injection moulding, and the leach liquors of PEEK and HA/PEEK gradient composites have no effects on the proliferative functions of osteoblast, with good osteoblast compatibility.


Polymers ◽  
2019 ◽  
Vol 11 (11) ◽  
pp. 1803
Author(s):  
Chon ◽  
Yang ◽  
Lee ◽  
Kim ◽  
Jeon ◽  
...  

In this research, we synthesized novel polyetheretherketone (PEEK) copolymers and evaluated the biosafety and cytotoxicity of their composites for spinal cage applications in the orthopedic field. The PEEK copolymers and their composites were prepared through a solution polymerization method using diphenyl sulfone as a polymerization solvent. The composite of PEEK copolymer showed good mechanical properties similar to that of natural bone, and also showed good thermal characteristics for the processing of clinical use as spine cage. The results of an in vitro cytotoxicity test did not show any evidence of a toxic effect on the novel PEEK composite. On the basis of these cytotoxicity test results, the PEEK composite also proved its in vitro biosafety for application to an implantable spine cage.


Nanomaterials ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 387
Author(s):  
Alfred Mensah ◽  
Yajun Chen ◽  
Benjamin K. Asinyo ◽  
Ebenezer Kofi Howard ◽  
Christopher Narh ◽  
...  

A “super” bioactive antibacterial hydrogel, Icariin-β-CD-inclusion complex/Bacterial cellulose and an equally capable counterpart Icariin-Bacterial cellulose (ICBC) were successfully produced with excellent antioxidant properties. The highly porous hydrogels demonstrated very high fluid/liquid absorption capability and were functionally active as Fourier Transform Infrared Spectrometer (FTIR) test confirmed the existence of abundant hydroxyls (-OH stretching), carboxylic acids (-CH2/C-O stretching), Alkyne/nitrile (C≡C/C≡N stretching with triple bonds) and phenol (C-H/N-O symmetric stretching) functional groups. Scanning electron microscope (SEM) and X-ray diffraction (XRD) tests confirmed a successful β-CD-inclusion complexation with Icariin with a great potential for sustained and controlled drug release. In vitro drug release test results indicated a systemic and controlled release of the drug (Icariin) from the internal cavities of the β-CD inclusion complex incorporated inside the BC matrix with high Icariin (drug) release rates. Impressive inactivation rates against Gram-negative bacteria Escherichia coli ATCC 8099 and gram-positive bacteria Staphylococcus aureus ATCC 6538; >99.19% and >98.89% respectively were recorded, as the materials proved to be non-toxic on L929 cells in the in vitro cytotoxicity test results. The materials with promising versatile multipurpose administration of Icariin for wound dressing (as wound dressers), can also be executed as implants for tissue regeneration, as well as face-mask for cosmetic purposes.


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