Cellulose fibres enhance the function of hemostatic composite medical sealants.

Tissue adhesives and sealants offer promising alternatives to traditional wound closure methods, but the existing trade-off between biocompatibility and strength is still a challenge. The current study explores the potential of a gelatin-alginate-based hydrogel, cross-linked with a carbodiimide, and loaded with two functional fillers, the hemostatic agent kaolin and cellulose fibres, to improve the hydrogel's mechanical strength and hemostatic properties for use as a sealant. The effect of the formulation parameters on the mechanical and physical properties was studied, as well as the biocompatibility and microstructure. The incorporation of the two functional fillers resulted in a dual micro-composite structure, with uniform dispersion of both fillers within the hydrogel, and excellent adhesion between the fillers and the hydrogel matrix. This enabled to strongly increase the sealing ability and the tensile strength and modulus of the hydrogel. The fibres' contribution to the enhanced mechanical properties is more dominant than that of kaolin. A combined synergistic effect of both fillers resulted in enhanced sealing ability (247%), tensile strength (400%), and Young's modulus (437%), compared to the unloaded hydrogel formulation. While the incorporation of kaolin almost did not affect the physical properties of the hydrogel, the incorporation of the fibres strongly increased the viscosity and decreased the gelation time and swelling degree. The cytotoxicity tests indicated that all studied formulations exhibited high cell viability. Hence, the studied new dual micro-composite hydrogels may be suitable for medical sealing applications, especially when it is needed to get a high sealing effect within a short time. The desired hemostatic effect is obtained due to kaolin incorporation without affecting the physical properties of the sealant. Understanding the effects of the formulation parameters on the hydrogel's properties enables the fitting of optimal formulations for various medical sealing applications.

Closure of Long Surgical Incisions with Hemostatic Tissue Adhesive in a Porcine Skin Model.

OBJECTIVE: Skin adhesives offer many advantages over traditional wound-closure devices. Recently, the current research group reported on tissue adhesives composed of natural polymers (gelatin and alginate), which are biocompatible with mechanical properties suitable for tissue adhesion. The objective of the present study was to conduct clinical and histologic assessment of this hemostatic bioadhesive in the healing of long skin incisions (≥4 cm) in comparison with traditional and commercially available methods. METHODS: Researchers created 24 long incisions on the ventral side of two domestic pigs to compare four different treatment modalities: two topical bioadhesives based on gelatin and alginate combined with the hemostatic agent kaolin, nylon sutures, and commercial tissue adhesive N-butyl-2-cyanoacrylate. The bioadhesive compounds were spread on the incision surface and then mixed either manually or with a double-headed syringe. After 14 days, clinical and histologic measurements were performed to evaluate the healing phase of the wounds. RESULTS: The bioadhesive formulation that contained a relatively low crosslinker concentration demonstrated superior results to the formulation that contained a standard crosslinker concentration. However, no significant statistical differences were observed compared with the control incisions (sutures and commercial adhesive N-butyl-2-cyanoacrylate). This was verified by immunohistochemical analysis for epithelial integrity and scar formation as well as by clinical assessment. CONCLUSIONS: This newly developed bioadhesive demonstrated suitable properties for the closure of long incisions in a porcine skin model.

In vivo study of the efficacy of bupivacaine-eluting novel soy protein wound dressings in a rat burn model.

Dealing with wound related pain is an integral part of treatment. Systemic administration of analgesic and anesthetic agents is a common solution for providing pain relief to patients but comes at a risk of severe side effects as well as addiction. To overcome these issues, research efforts were madeto provide a platform for local controlled release of pain killers. We have developed a bilayer soy protein-based wound dressing for the controlled local release of bupivacaine to the wound site. The combination of a dense and a porous layer provides a platform for cell growth and proliferation as well as physical protection to the wound site. The current study focuses on the in vitro bupivacaine release profile from the dressing and the corresponding in vivo results of pain levels in a second-degree burn model on rats. The Rat Grimace Scale method and the Von Frey filaments method were used to quantify both, spontaneous pain and mechanically induced pain. A high burst release of 61.8 ± 1.9% of the loaded drug was obtained during the initial hour, followed by a slower release rate during the following day. The animal trials show that the RGS scores of the bupivacaine-treated group were significantly lower than these of the untreated group, proving a decrease of 51-68% in pain levels during days 1-3 after burn. Hence, successful pain reduction of spontaneous pain as well as mechanically induced pain, for at least three days after burn was achieved. It is concluded that our novel bupivacaine eluting soy protein wound dressings are a promising new concept in the field of local controlled drug release for pain management.

Cell viability of novel composite hydrogels loaded with hydroxyapatite for oral and maxillofacial bone regeneration.

The development of hydrogels for maxillofacial bone regeneration holds vast potential. However, some challenges need to be addressed to further their application in clinical settings. One challenge is optimizing cell viability. To improve mechanical strength, various materials have been investigated; however, incorporation of these materials within the hydrogel network may affect cell viability. The purpose of this study was to evaluate the cell viability of novel gelatin-alginate composite hydrogels loaded with hydroxyapatite (HA) and nano-hydroxyapatite (n-HA) for maxillofacial bone regeneration. Nine different hydrogels were prepared: three loaded with 0.5%, 1%, and 3% w/v HA; three loaded with 0.25%, 0.5%, and 1% w/v n-HA; one not loaded as a control and two HA and n-HA hydrogels with a lower concentration of the EDC crosslinker. Cell viability of human osteoblasts exposed to the hydrogels as affected by the HA type, size, and concentration, as well as to the crosslinker concentration, was investigated. An Alamar Blue assay was used to evaluate cell viability in the presence of hydrogel extracts and in aqueous solutions (without the hydrogel). A qualitative model was developed for explaining cell viability and growth. Higher percentages of cell viability were observed in the hydrogels loaded with hydroxyapatite as compared with the control. The effect of HA-related parameters, i.e., particle size and concentration, was found to increase the cytotoxic effect, as expressed in lower cell viability. The most favorable composites were the n-HA hydrogels. The incorporation of n-HA in the hydrogel to form a composite seems to be a very promising approach for maxillofacial bone regeneration applications.

Effect of implant neck design on primary and secondary implant stability in the posterior maxilla: A prospective randomized controlled study.

OBJECTIVE: To compare the early changes in implant stability of implants with different neck design during the first 3 months of healing in the posterior maxilla. MATERIALS AND METHODS: Patients were randomized to receive triangular neck implant (test), or round neck implant (control). Resonance frequency analysis (ISQ) measurements were obtained at surgery and at 2, 4, 7, 14, 21, 28, 45, 60, and 90 days following implant placement. Non-parametric statistic was used for data analysis. RESULTS: Thirty-two patients were included (17 test and 15 controls). Initial ISQ values of the test implants were high (mean: 68.4, SD = 8.4) and increased over time (mean: 74.4, SD = 6.0). Control implants presented a statistically significant higher initial ISQ value at implant placement (mean: 76.9, SD = 8.7), which was maintained over the healing period (mean: 77.6, SD = 3.6) with no significant changes between time intervals. After 6 weeks of healing, both implants displayed comparable ISQ values with no differences between the groups. All implants exhibited a decrease in stability on days 2 and 21 post-placement. All roundneck implants used, and 82% of the triangularneck implants showed initial ISQ values above the suggested threshold for immediate loading (>60). CONCLUSIONS: Implant neck design plays a role in implant primary stability in the posterior maxilla. Both implants show high primary stability, with significantly higher values for the round neck. However, these differences disappeared after 6 weeks of healing. While primary implant stability is partially governed by implant neck design, the role of this result is negligible for the achievement of secondary stability.

Bone microstrain values of 1-piece and 2-piece implants subjected to mechanical loading.

PURPOSE: The purpose of this study was to measure and compare the strain levels in peri-implant bone as generated by 1-piece (1P) and 2-piece (2P) implant systems. MATERIALS AND METHODS: The implants (1P and 2P) were placed into bovine bone according to the manufacturer's protocol. Four linear strain gauges were placed around each implant neck and apex. Each model was loaded in static loading by a material testing machine in ascending forces ranging from 20 to 120 N. Microstrains (µ[Latin Small Letter Open E]) generated in the surrounding bone were measured by a strain gauge and recorded. RESULTS: Recorded microstrains were significantly higher for 1P implants than for 2P implants. Average recorded microstrain values were significantly lower in the neck (71.6 and 17.3 µs) compared with the apical (132 and 60 µs) regions of 1P and 2P implants, respectively (P < 0.0001). CONCLUSIONS: Within the limitations of this study, highest microstrains were generated in apical regions regardless of implant design, but the 2P implant ap-peared to provide a stress-damping effect in both the cervical and apical regions compared with the 1P implant.