Pilot scale-up and shelf stability of hydrogel wound dressings obtained by gamma radiation

This study is aimed of producing pilot batches of hydrogel wound dressings by gamma radiation and evaluating their shelf stability. Six batches of 3L capacity were prepared based on poly(vinyl pyrrolidone), agar and polyethylene glycol and they were dispensed in polyester trays, covered with polyester films and sealed in two types of materials: polyethylene bags and vacuum polyethylene bags. Dressings were formed in a single step process for the hydrogel formation and sterilization at 25–30 kGy gamma radiation dose in a JS-9500 Gamma Irradiator (Nordion, Canada). The six batches were initially physicochemical characterized in terms of dimensions and appearance, gel fraction, morphology analysis, hydrogel strength, moisture retention capability and swelling capacity. They were kept under two storage conditions: room temperature (T: 30±2 °C/RH: 70± 5%) and refrigerated temperature (T: 5±3 °C) during 24 months and sterility test was performed. The appearance of membranes was transparent, clear, uncut and flexible; the gel fraction of batches was higher than 75% and the hydrogel surface showed a porous structure. There was a slow decrease of the compression rate 20% until 7 h and about 70% at 24 h. Moisture retention capability in 5 h was similar for all the batches, about 40% and 60% at 37 °C and at room temperature respectively. The swelling of hydrogels in acidic media was strong and in alkaline media the weight variation remains almost stable until 24 h and then there is a loss of weight. The six batches remained sterile during the stability study in the conditions tested. The pilot batches were consistent from batch to batch and remained stable during 24 months.     

Studies on the disposable obstetrical dressings sterilized by radiation and the effect of its application

In order to attain an optimum sterilization treatment to obstetric dressings, a new product made by us, with ⁶⁰Coγ-ray, the effects of radiation on standard bacteria pseudomonas aeruginosa ATcc27853, Escherichia coli ATcc25922, Staphylococcus aureus ATcc25923, Clostridium PB6KA, short Bacillus E60163202 and HBSAg were studied. Results showed that at the absorbed dose of 10 kGy, all the bacteria, bacillus and HBSAg were killed off, and sterilized with the dose, the dressings can completely accord with the demands of hygiene, which was further confirmed by microbiological and poisonous tests and the effects of clinical application. In Nov. 1988, the dressings was awarded the excellent prize in the 1st international exhibition of patent, new technique and new equipment in Guangzhou; its effective application is also reported in the paper.     

Multifunctional fibrous wound dressings for refractory wound healing

Refractory wounds have always been an important issue to healthcare systems, whose healing process is always delayed by multiple factors, including bacterial infections, chronic inflammation, and excessive exudates, etc. Employing multifunctional wound dressings is recognized as an effective strategy to deal with refractory wounds, which has yielded promising outcomes in recent years. Among these advanced wound dressings, fibrous dressings have gained growing attention due to their unique merits. Such wound dressings have demonstrated great potential in delivering theranostic agents, such as antibacterial agents, anti-inflammatory drugs, growth factors, and diagnostic probes, etc., for the purposes of accelerating wound healing. This paper reviews the development of multifunctional fibrous dressings and their applications in treating refractory wounds. The construction approaches of novel fibrous dressing with capabilities of antibacterial, anti-inflammation, exudate management and diagnosis were also introduced. Furthermore, the existing problems and challenges are also discussed briefly.     

Accredited dose measurements for validation of radiation sterilized products

The activities and services of the accredited Risø High Dose Reference Laboratory are described. The laboratory operates according to the European standard EN 45001 regarding Operation of Testing Laboratories, and it fulfills the requirements of being able to deliver traceable dose measurements for control of radiation sterilization. The accredited services include:

1. 1. Irradiation of dosimeters and test samples with cobalt-60 gamma rays.

2. 2. Irradiation of dosimeters and test samples with 10 MeV electrons.

3. 3. Issue of and measurement with calibrated dosimeters.

4. 4. Measurement of the dosimetric parameters of an irradiation facility.

5. 5. Measurement of absorbed dose distribution in irradiated products.

The paper describes these services and the procedures necessary for their execution.     

Adapting resistive sensors for monitoring moisture in smart wound dressings

Moisture plays a critical role in the wound healing process and, given the multitude of electrochemical sensors aimed at measuring humidity, it is somewhat surprising that there are few systems dedicated to this particular application. The issues relating to wound moisture and the practical challenges facing the adaptation of generic resistive moisture sensors to this area are considered along with the potential impact such systems could have on nursing practice.     

Convergent architecting of multifunction-in-one hydrogels as wound dressings for surgical anti-infections

Surgical procedures are susceptible to the cause of infections, which could induce delayed wound healing, oxidative stress and tissue ischemia. Multifunctional wound dressings (e.g., hydrogels) without the induction of antibiotics is promising for the elimination of surgical site infections and the associated complications. Herein, we report a reductionism approach for the fabrication of bioactive hydrogels to recapitulate antibacterial functions as well as antioxidant, pro-angiogenic and hemostatic properties in surgical infection treatments. The hydrogels composed of naturally derived Cirsium setosum extracts (CE, a traditional medicinal herb) and carboxymethyl chitosan (CS) show their capacity for surgical anti-infections on three different models (i.e., infectious random skin flap model, infectious skin defect model and infectious femur fracture model). Due to the innate bioactivities of CE and CS, CECS hydrogels can also reduce the bleeding loss (85% reduction) on a hemorrhaging liver model and improve the vascularization for skin flap regeneration. Overall, bioactive CECS hydrogels integrated with the ease and scalability of assembly process and biological activities without the addition of antibiotics is promising to act as multifunctional wound dressings for surgical anti-infections.     

Development of sterculia gum based wound dressings for use in drug delivery

The present study deals with the modification of sterculia gum to develop the novel wounds dressing for the delivery of antimicrobial agent (tetracycline hydrochloride). The sterculia crosslinked PVA (sterculia-cl-PVA) hydrogels were characterized by FTIR and swelling studies. For the evaluation of swelling and drug release mechanism, the swelling kinetics and in vitro release dynamics of model drug from this matrix were studied in solution of different pH and simulated wounds fluid. Per gram of polymer has taken (8.3 ± 0.1) g of simulated wounds fluid and has released (0.820 ± 0.6) mg of drug in the simulated fluid. The value of the ‘n’ (0.84) indicates the non-Fickian diffusion mechanism for the release of drug in simulated fluids.     

Alteration of yeast activity by gamma radiation

Yeast is an important component in microbe based industrial technologies. Due to the techno-economic reasons, the fermentation technique has acquired renewed interest. The effect of -radiation on the fermentation reaction has been investigated. The studies show that exposure of the fermentation mixture to -radiation at 5 kGy enhance alcohol production, whereas irradiation at higher doses, viz., 10 kGy and 25 kGy caused a considerable reduction in the alcohol yield. Therefore, low dose irradiation of fermentation mixtures can be applied for increasing the alcohol production by about 25%.     

Injectable and self-healing hydrogels with tissue adhesiveness and antibacterial activity as wound dressings for infected wound healing

The design of wound dressings with excellent self-healing ability, adequate adhesion, good biocompatibility, and potential antibacterial ability is of great significance for the healing of infected wounds arising from human activities. Herein, a series of multi-functional hydrogel dressings, poly(ionized isocyanoethyl methacrylate-glutamine)/poly(hexamethylene guanidine) (iG_x/PHMG_y) hydrogels, were obtained through homopolymerization of fully ionized isocyanoethyl methacrylate-glutamine (iIEM-Gln) in the presence of poly(hexamethylene guanidine) (PHMG), in which strong hydrogen bonds were formed among urea groups in the P (iIEM-Gln) chain to form a stable hydrogel network. The prepared iG_x/PHMG_y hydrogels exhibited adequate self-healing ability and tissue adhesion, which could be firmly adhered to the wound surface and remained intact during application. In addition, the presence of PHMG imparted good antibacterial activity to the hydrogels for the effective promotion of the wound healing in S. aureus infected skin wound on mice. Overall, this multi-functional hydrogel provides a facile and effective strategy for the design of infected wound dressings, and may show great potential in clinical applications.     

Engineering quaternized chitosan in the 3D bacterial cellulose structure for antibacterial wound dressings

Balancing antibacterial properties with biocompatibility is of paramount importance for wound dressings loaded with antibacterial agents. In this work, a water soluble antibacterial agent, quaternized chitosan (hydroxypropyltrimethyl ammonium chloride chitosan, HACC) with an appropriate degree of substitution was introduced into the bacterial cellulose (BC) network by adding it into the BC culture medium. Results indicated that the addition of HACC could affect the yield of BC, porous structure, thermal stability, water absorption and antibacterial properties. HBC-1 with a low content of HACC (13.65 ± 0.30%) cannot inhibit the biofilm formation of bacteria, while HBC-3 with a high content of HACC (62.05 ± 0.90%) has a low yield of BC and confused structure. HBC-2 with an optimum concentration of HACC (37.33 ± 0.80%) possessed a typical porous structure, acceptable thermal stability, good water absorption and favorable antibacterial properties against Staphylococcus aureus (S. aureus, ATCC 25923) and methicillin-resistant S. aureus (ATCC 43300). Most importantly, none of the HACC/BC films exhibited cytotoxicity to NIH3T3 cells. We believe that obtained HACC/BC films with favorable bactericidal properties and biocompatibility could be potential candidates for wound dressings in clinical applications.     

Electrospun cellulose acetate wound dressings loaded with Pramipexole for diabetic wound healing: an in vitro and in vivo study

In the current study, a Pramipexole-loaded wound dressing was produced via electrospinning of cellulose acetate solution. Pramipexole was added to cellulose acetate solution at 3, 5, and 10% w/w concentrations and then electrospun. The produced wound dressings were studied regarding their physicochemical and biological properties. Results of cell viability assay and cytoprotection studies showed that cellulose acetate wound dressings containing 3% w/w Pramipexole had significantly higher cell viability compared with other concentrations. The wound healing potential of dressings incorporated with 3% drug was studied in a rat model of diabetic wound. Study showed that the cellulose acetate/3% Pramipexole scaffolds had significantly higher percentage of wound closure, epithelial thickness, and collagen deposition compared with drug-free dressings and control group. Gene expression study showed that the drug-loaded wound dressings could reduce oxidative stress and alleviate inflammation at significantly higher extent compared with other groups.

     

Protein-based fluorescent bioassay for low-dose gamma radiation exposures

Analytical and Bioanalytical Chemistry - The study suggests an application of a coelenteramide-containing fluorescent protein (CLM-CFP) as a simplest bioassay for gamma radiation exposures....     

Controlling size and stabilization of silver nanoparticles for use in optimized chitosan-dialdehyde xylan wound dressings

The size of silver nanoparticles (AgNPs) is the key factor that governs their antibacterial activity. However, the size of AgNPs is difficult to control because agglomeration and uneven dispersion often occur during the processing of AgNP-based products, which has impeded their applications in different areas. In this work, an efficient strategy was developed to overcome this difficulty and to prepare an antibacterial hydrogel comprising AgNPs and chitosan (CS) with dialdehyde xylan (DAX) as the crosslinking agent. The size of AgNPs was controlled successfully to an extremely fine level (<?9 nm) by reducing AgNO₃ solution in a methanolic suspension of the metal organic framework (MOF) -UiO-66-NH₂, and forming an Ag@UiO-66-NH₂ core–shell structure which avoided the agglomeration of AgNPs. DAX played a dual role by forming a hydrogel structure with CS through crosslinking, but also by stabilizing the even dispersion of Ag@UiO-66-NH₂ in the hydrogel. Accordingly, the as-prepared hydrogels showed excellent antibacterial properties and low cytotoxicity. The survival ratio of NIH/3T3 cells cultured in the hydrogel extract was more than 90%, even when the concentration of the hydrogel extract was as high as 10 mg/mL. In addition, the hydrogel exhibited good abilities of water absorption (swelling ratio was up to 1100%) and self-healing (efficiency was up to 88% after 5 h). The hydrogels with size-well-controlled AgNPs prepared in this work are expected to find broad applications, especially in the area of antibacterial medical auxiliaries.

     

Fabrication and characterization of electrospun silk fibroin/TiO2 nanofibrous mats for wound dressings

Silk fibroin (SF) nanofibrous mats were fabricated via electrospinning process. These fibers were blended with TiO₂ nanoparticles (TiO₂ NPs). The influence of TiO₂ NPs on the nanofibrous matrices was investigated by scanning electron microscopy (SEM), transmission electron microscopy, energy‐dispersive X‐ray, and thermogravimetric analysis. The SEM images revealed that the average diameter of the SF/TiO₂ fibers was 385 ± 63 nm when the concentration of SF was up to 10% (w/v). Infrared spectra showed that the β‐sheet structure of the silk fibroin increased after acetone treatment. These SF/TiO₂ nanofibrous mats exhibited higher equilibrium water content and water vapor transmission rate than hydrocolloid dressing. The hemocompatibility and cytocompatibility of SF/TiO₂ nanofibrous mats were evaluated by complete blood count, cell attachment, and the spreading of L929 fibroblasts. These SF/TiO₂ nanofibrous mats exhibited antibacterial activity against Escherichia coli under UV irradiation. Thus, these novel nanocomposite mats may be used for biomedical applications such as wound dressing. Copyright © 2011 John Wiley & Sons, Ltd.     

Slow release of wound healing drug from hydrogel wound dressing prepared by radiation crosslinking method

The hydrogel wound dressing was prepared by radiation crosslinking. It was used of on patients in the Navy 411 Hospital and some other hospitals. From sixty case studies of the clinical effects, the results showed that: 1. drug releasing slowly releives the pain effectively for prolonged period of application; 2. The dressing can reduce the oozing liquid from the wound and make the wound heal faster; 3. The number of the dressing change is greatly reduced. All the data indicates that the dressing is superior to the conventional kinds.     

Improvement of microbiological safety of sous-vide meals by gamma radiation

Experimental batches of smoked-cured pork in stewed beans sauce were inoculated with spores of psychrotrophic Bacillus cereus, more heat and radiation resistant than spores of non-proteolytic C. botulinum. After vacuum packaging, the meals were treated with combinations of pasteurizing heat treatments and gamma irradiation of 5 kGy. Prior and after treatments, and periodically during storage at 10°C, total aerobic and total anerobic viable cell counts, and selectively, the viable cell counts of B. cereus and sulphite-reducing clostridia have been determined. The effects of the treatment order as well as addition of nisin to enhance the preservative efficiency of the physical treatments were also studied. Heat-sensitization of bacterial spores surviving irradiation occurred. The quality-friendly sous-vide cooking in combination with this medium dose gamma irradiation and/or nisin addition increased considerably the microbiological safety and the keeping quality of the meals studied. However, approx. 40% loss of thiamin content occurred as an effect of combination treatments, and adverse sensorial effects may also limit the feasible radiation doses or the usable concentrations of nisin.     

Preparation of chitosan–polyethylene glycol coated cotton membranes for wound dressings: preparation and characterization

Cotton fabric was coated with chitosan (CS) and polyethylene glycol (PEG) followed by freeze‐drying. The influence of PEG on the physical characteristics and the surface morphology was investigated. The scanning electron microscopy of the coated fabric revealed a porous structure. The porosity of the material was 54–70% and the pore size was in the range of 75–120µm. The increase in the PEG content in the blend composition led to an enhanced destabilization of pores, leading to an increase in the pore size with elongated morphology. There seems to be phase separation between the two components which is an important factor for the observed behavior of the porous structure. The Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) showed that the CS and PEG have limited interaction. DSC suggested that addition of PEG to CS does not interfere with the crystallization behavior due to limited interaction with CS. The thermogravimetric analysis (TGA) showed that the membranes are thermally stable and PEG enhances the thermal stability of the CS coated membranes. The air and water permeability of the membranes tended to decrease with the increase in the PEG content. Copyright © 2008 John Wiley & Sons, Ltd.     

Poly(methyloctadecylsiloxane) immobilized on silica by gamma radiation for use in solid-phase extraction

The suitability of using metal-loaded sorbents for solid-phase extraction to enrich organic sulfur compounds from water samples was studied. To test the retention behavior of a number of sulfides, thiols and methylthiophosphates, a cation-exchanger was loaded with various metal ions. The elution behavior of sulfur compounds was investigated with different solvents. A combination of Pb2+-modified cation-exchanger as sorbent and CS2 (1%, v/v) in toluene proved to be the most suitable approach for the given problem. Using GC with a pulsed flame photometric detector yielded detection limits of between 0.6 and 2.9 microg/l. The results showed good reproducibility with relative standard deviations of 2-11%.