Endotoxin contamination in wound dressings made of natural biomaterials

Nakagawa, Yukari; Murai, Toshimi; Hasegawa, Chie; Hirata, Michimasa; Tsuchiya, Toshie; Yagami, Takeshi; Haishima, Yuji

doi:10.1002/jbm.b.10020

Cited by 58 publications

(35 citation statements)

References 30 publications

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“…16 Although it is difficult to correlate problems with medical devices with pyrogenic contamination retrospectively and the awareness for their adverse influence may not yet be very high, some reports strongly indicate a role of pyrogens in problematic medical devices, especially those made of or coated with materials of biological origin. 7,8,23 Taken together, using a model implantable material, we have shown that the IPT can be used to evaluate pyrogenic contaminations on medical devices. This assay could lead to a replacement of the rabbit pyrogen assay for this application and could improve current safety testing of biomaterials.…”

Section: Discussionmentioning

confidence: 96%

“…One prob-lem is that the rabbit may respond differently to some pyrogenic contaminations than a human. 8,9 Also, this method can only be performed with small implants. The destruction of tissue during implantation into the animal may itself cause an inflammatory reaction that does not necessarily reflect the pyrogenic contamination of the material.…”

Section: Introductionmentioning

confidence: 99%

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In vitro pyrogen test—A new test method for solid medical devices

Mazzotti

Beuttler

Zeller

et al. 2006

J Biomedical Materials Res

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Medical devices manufactured for implantation into humans must be free of any contamination with viable bacteria. However, remnants of dead bacteria and bacterial components alone may induce an inflammatory immune response. Pyrogen tests for such inflammatory contaminations are generally performed either by determining the content of lipopolysaccharide in rinsing solutions of batch samples by limulus amoebocyte lysate assay, by injecting the rinsing solutions into rabbits or by implanting batch samples into rabbits and measuring change of body temperature. In this study, we show that the in vitro pyrogen test (IPT), which measures the release of the inflammatory cytokine IL-1beta in fresh or cryopreserved human whole blood, can be used to assess the pyrogenic contamination of implantable medical devices. This test was used to check neurosurgical implants, namely aneurysm clips, as a proof of principle. Owing to the direct contact of the test material with the blood cells, this test does not require rinsing procedures, which have variable efficacy. The use of human blood ensures the detection of all substances that are pyrogenic for humans and reflects their relative potency. The safety of the products as delivered could be confirmed. The effects of sterilization and depyrogenization procedures on intentional pyrogenic contaminations of samples could be followed. This new application of the already internationally validated method promises to replace further rabbit pyrogen tests. It generates extremely sensitive results with an extended range of detectable pyrogenic contaminants.

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Section: Discussionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

In vitro pyrogen test—A new test method for solid medical devices

Mazzotti

Beuttler

Zeller

et al. 2006

J Biomedical Materials Res

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show abstract

“…), as described elsewhere [22]. Endotoxin detection was performed by Analytical Services Unit of iBET, Oeiras, Portugal using a Charles River endotoxin detection kit.…”

Section: Measurement Of Endotoxin Levelsmentioning

confidence: 99%

Macrophage interactions with polylactic acid and chitosan scaffolds lead to improved recruitment of human mesenchymal stem/stromal cells: a comprehensive study with different immune cells

Caires

Esteves

Quelhas

et al. 2016

J. R. Soc. Interface.

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Despite the importance of immune cell-biomaterial interactions for the regenerative outcome, few studies have investigated how distinct three-dimensional biomaterials modulate the immune cell-mediated mesenchymal stem/stromal cells (MSC) recruitment and function. Thus, this work compares the response of varied primary human immune cell populations triggered by different model scaffolds and describes its functional consequence on recruitment and motility of bone marrow MSC. It was found that polylactic acid (PLA) and chitosan scaffolds lead to an increase in the metabolic activity of macrophages but not of peripheral blood mononuclear cells (PBMC), natural killer (NK) cells or monocytes. PBMC and NK cells increase their cell number in PLA scaffolds and express a secretion profile that does not promote MSC recruitment. Importantly, chitosan increases IL-8, MIP-1, MCP-1 and RANTES secretion by macrophages while PLA stimulates IL-6, IL-8 and MCP-1 production, all chemokines that can lead to MSC recruitment. This secretion profile of macrophages in contact with biomaterials correlates with the highest MSC invasion. Furthermore, macrophages enhance stem cell motility within chitosan scaffolds by 44% but not in PLA scaffolds. Thus, macrophages are the cells that in contact with engineered biomaterials become activated to secrete bioactive molecules that stimulate MSC recruitment.

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“…In order to facilitate the wound healing process, a range of natural biomaterials have been developed, based on cellulose, alginate, collagen and chitin, among others (Nakagawa et al, 2003). Bacterial cellulose is produced by some types of bacteria, such as Gluconacetobacter (Inder & Brown, 2012), and has been suggested for various medical applications, such as wound dressings (Czaja, Krystynowicz, Bielecki & Brown Jr, 2006;Jorfi & Foster, 2015;Petersen & Gatenholm, 2011;Portal, Clark & Levinson, 2009).…”

Section: Introductionmentioning

confidence: 99%

Producing ultrapure wood cellulose nanofibrils and evaluating the cytotoxicity using human skin cells

Nordli

Chinga-Carrasco²,

Rokstad

et al. 2016

Carbohydrate Polymers

103

125

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 Cellulose nanofibril dispersion (50 µg/ml) did not affect the cytotoxicity or metabolic activity of Normal Human Dermal Fibroblasts and Human Epidermal Keratinocytes  Aerogels made of cellulose nanofibrils induced a reduction of metabolic activity by the fibroblasts and keratinocytes, but no significant cell death  Cytokine profiling measuring 27 cytokines revealed that the keratinocytes and fibroblasts did not induce cytokines upon direct exposure to the CNF materials. Due to the nano dimension of the CNFs, the aerogels had a high moisture-holding capacity (~7500%) 3 AbstractWood cellulose nanofibrils have been suggested as a potential wound healing material, but its utilization is limited by FDA requirements regarding endotoxin levels. In this study a method using sodium hydroxide followed by TEMPO mediated oxidation was developed to produce ultrapure cellulose nanofibrils (CNF), with an endotoxin level of 45 endotoxin units/g (EU/g) cellulose. Scanning transmission electron microscopy (S(T)EM) revealed a highly nanofibrillated structure (lateral width of 3.7±1.3 nm).Assessment of cytotoxicity and metabolic activity on Normal Human Dermal Fibroblasts and Human Epidermal Keratinocytes was done. CNF-dispersion of 50 g/ml did not affect the cells. CNF-aerogels induced a reduction of metabolic activity by the fibroblasts and keratinocytes, but no significant cell death. Cytokine profiling revealed no induction of the 27 cytokines tested upon exposure to CNF. The moisture-holding capacity of aerogels was relatively high (~7500%), compared to a commercially available wound dressing (~2500%),indicating that the CNF material is promising as dressing material for management of wounds with a moderate to high amount of exudate.

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Endotoxin contamination in wound dressings made of natural biomaterials

Cited by 58 publications

References 30 publications

In vitro pyrogen test—A new test method for solid medical devices

In vitro pyrogen test—A new test method for solid medical devices

Macrophage interactions with polylactic acid and chitosan scaffolds lead to improved recruitment of human mesenchymal stem/stromal cells: a comprehensive study with different immune cells

Producing ultrapure wood cellulose nanofibrils and evaluating the cytotoxicity using human skin cells

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