Significant Foreign Body Reaction Research Articles

Stable fixation using absorbable sutures in craniofacial surgery in patients over 24 months of age—a retrospective study

PurposeIn craniofacial surgery, the stable fixation of transposed bone segments is crucial in order to ensure good long-term results. The use of absorbable material in fixation avoids the need for a second surgery, which would otherwise be required to remove osteosynthesis material. The authors of the present manuscript have already demonstrated that absorbable sutures ensure the stable fixation of bone segments in patients up to 24 months of age. However, it has thus far remained unclear whether stable fixation is possible in older patients by using only absorbable sutures due to the slower bone remodelling and prolonged healing time in this cohort.MethodFor the present study, osteosynthesis was performed in 50 patients ranging from 25.7 to 192.1 months of age (mean, 61.4 ± 21.7 months) using solely absorbable sutures (PDS II®, Ethicon, Germany). Post-operative stability and possible restrictions—such as foreign body reactions—were evaluated within clinical and radiological routine follow-ups.ResultsAll children demonstrated clinically and radiologically stable osteosynthesis both directly post-operatively and in follow-ups. No significant foreign body reaction could be seen.ConclusionThe present study demonstrates—for the first time—that absorbable sutures with a longer absorption period are also very well suited for the fixation of bone segments in patients over 24 months of age. The sole use of absorbable sutures in children over 24 months of age is a safe procedure with nearly no foreign body reactions. The procedure enables stable and highly cost-effective osteosynthesis without altering the osteotomy design.

Antibacterial and Immunomodulatory Properties of Acellular Wharton's Jelly Matrix.

Of all biologic matrices, decellularized tissues have emerged as a promising tool in the field of regenerative medicine. Few empirical clinical studies have shown that Wharton’s jelly (WJ) of the human umbilical cord promotes wound closure and reduces wound-related infections. In this scope, we herein investigated whether decellularized (DC)-WJ could be used as an engineered biomaterial. In comparison with devitalized (DV)-WJ, our results showed an inherent effect of DC-WJ on Gram positive (S. aureus and S. epidermidis) and Gram negative (E. coli and P. aeruginosa) growth and adhesion. Although DC-WJ activated the neutrophils and monocytes in a comparable magnitude to DV-WJ, macrophages modulated their phenotypes and polarization states from the resting M0 phenotype to the hybrid M1/M2 phenotype in the presence of DC-WJ. M1 phenotype was predominant in the presence of DV-WJ. Finally, the subcutaneous implantation of DC-WJ showed total resorption after three weeks of implantation without any sign of foreign body reaction. These significant data shed light on the potential regenerative application of DC-WJ in providing a suitable biomaterial for tissue regenerative medicine and an ideal strategy to prevent wound-associated infections.

Effectiveness of cross-linked human acellular dermal matrix in primary and revision augmentation rhinoplasty

Among the materials used for dorsal augmentation rhinoplasty (DAR), cross-linked human acellular dermal matrix (ADM) has been claimed for its low risk of infection and extrusion. The aim of this study was to compare the effectiveness of ADM in subjects undergoing primary versus revision dorsal augmentation rhinoplasties. Using a retrospective cohort study design, the investigators enrolled a cohort set of DAR patients operated by a single surgeon during a 65-month interval. The predictor variable was the treatment group (primary or revision DAR). The main outcome variables were postoperative changes with regard to the degree of augmentation (ratio of the dorsal height [DH] and radix height [RH] to the nasal length) and patients' and surgeons' satisfaction with the aesthetic and functional results. Other study variables were grouped into the following categories: demographic, surgical, and pathological. Descriptive, uni-, and bivariate statistics were computed using P ≤ 0.05 as a cutoff value. The study cohort comprised 145 subjects (75.2% with primary DAR; 39.3% females) with a mean age of 30.7 ± 9.4 years (range, 19-58). DAR was linked to the significant changes in DH and RH in both the treatment groups. Comparison of the two groups revealed that there was no significant difference in DH and RH between both the groups. Surgeons' and patients' satisfaction rates were comparable between the two surgery groups, neither of which experienced serious complications. Microscopic findings of the removed ADM showed abundant collagen tissue with newly formed vessels without signs of foreign body reaction. Despite significant differences in patient characteristics (age; number of osteotomy, tip plasty, and hump reduction surgeries), the results of this study suggest that ADM can be used in both primary and revision DAR, with minimal complications.

Ultrasound-assisted foreign body extraction (U-SAFE): Review of technique and technical pearls.

Soft tissue foreign bodies are a common presentation to emergency departments and primary care. They have variable presentations and associated morbidity depending on their acuity, location, functional impairment and neurovascular involvement. Traditional removal has utilised blind technique or surgical exploration. Their removal can be difficult secondary to induration, inflammation, granulation and scar tissue. Ultrasonography has emerged as a minimally invasive and inexpensive method of examination and retrieval. This article entails ultrasound-guided foreign body extraction with associated pearls of experience. From March 2017 to August 2020, a fellowship trained interventional radiologist and a fellowship trained musculoskeletal radiologist performed 52 foreign body extractions under ultrasound guidance at a single institution. 52 foreign body extractions occurred over 3-year time period with a 95% success rate. The most common location of foreign body was the finger (62%) and feet/toes (17%). Foreign bodies identified include wood (31%), plant-based material (29%), metal (17%), glass (17%) and synthetic material (6%). Two unsuccessful cases were secondary to delayed presentation with significant foreign body reaction and the 2nd due to patient psychiatric issues. There were no identified complications. Ultrasonography-guided foreign body extraction is a minimally invasive, efficient and targeted technique for foreign body removal.

Povidone-iodine Does Not Affect Acellular Dermal Matrix Integration in Patients Undergoing 2-staged, Prepectoral, Breast Reconstructive Surgery

Background:Povidone-iodine has been traditionally used as an antimicrobial agent to irrigate the breast pocket and rinse the prosthesis before placement in the pocket. Use of povidone-iodine with breast implants was banned from 2000 to 2017. During this period, acellular dermal matrix (ADM) was introduced to breast surgery. In nonclinical studies, povidone-iodine can impair collagen synthesis and kill fibroblasts. Cellular repopulation was critical for ADM integration. Whether povidone-iodine impacts ADM integration was unknown.Methods:Patients who underwent immediate, prepectoral, 2-staged breast reconstruction were included in this retrospective study. Study population was divided into povidone-iodine–treated patients and triple-antibiotic–treated patients. The breast pockets were rinsed with the antimicrobial agent, and the prostheses and ADMs were presoaked in the agent perioperatively. At implant exchange, the extent of ADM integration was clinically assessed. ADM integration was defined as >25% of matrix vascularization. ADM integration and postoperative complications were compared between the groups.Results:A total of 111 patients (257 reconstructions) were included—58 patients (111 reconstructions) were exposed to povidone-iodine and 53 patients (97 reconstructions) to triple-antibiotic solution. ADM integration was noted in 97% of breasts in each group. Integrated matrices appeared healthy, had no signs of foreign body reaction, and demonstrated punctate bleeding. Complications did not differ between the groups, including the rate of infections, seroma, and expander loss.Conclusion:Irrigation of the breast pocket and presoaking of the prosthesis and ADM with povidone-iodine appear to have no adverse consequences on clinical outcomes and did not impede matrix integration.

Absorbable sutures for the achievement of stable osteosynthesis in surgery for craniosynostosis.

The goal of the present study was to analyse the exclusive use of absorbable suture material (Vicryl) in the fixation of transposed bone segments in cranial vault reshaping without modification of the osteotomy design. In the surgical correction of craniosynostosis, bone fixation using osteosynthesis is a key step. Absorbable osteosynthesis is a widespread tool in cranial vault remodelling, but only a limited number of studies have described the use of absorbable sutures in the treatment of patients with craniosynostosis. In 72 children with various types of craniosynostosis, up to 24 months of age, osteosynthesis was conducted exclusively with Vicryl sutures. All patients were evaluated for the stability of postoperative results, and foreign body reactions were examined as part of the routine clinical and radiological follow-up ranging from 1 to 36 months. All examined children exhibited stable postoperative conditions with immediate stability of all remodelled cranial vaults. 2D and 3D radiological examinations demonstrated good bony union in all cases. Significant foreign body reactions were not observed and bone healing was noted at all sites. The exclusive application of absorbable suture material enables stable and cost-effective osteosynthesis in craniofacial surgery without altering the osteotomy design.

Histological analysis of different local haemostatic agents used for periapical surgery: An experimental study with Sprague-Dawley rats.

The aim of the present study was to analyse differences in the tissue response to the different haemostatic agents used for periapical surgery (BloodSTOP iX® (oxicellulose), Expazen® (aluminum chloride), calcium sulphate (CS), Gelatamp® (gelatin sponge) and Hemocor® (ferric sulphate). Seventy-two bone defects were made on the calvarium of 36 Sprague-Dawley rats. The specimens were euthanised at 3, 6 and 12weeks. Histological analysis revealed a giant cell foreign body reaction against BloodStop iX® , Gelatamp® and Hemocor® . Leukocytes persisted at the surgical bed during the healing process longer as expected with Gelatamp® (6weeks) and Hemocor® (12weeks). We confirmed a generalised delay in bone formation. Calcium sulphate did not cause any foreign body reaction. CS showed excellent results with a high degree of compatibility, there was no inflammatory reaction with this agent after 12weeks and was not associated with a significant foreign body reaction at any time during the study.

The effect of poly-p-dioxanone plate on the protection and vitality of cartilage: An animal study.

In septorhinoplasty, septal, auricular, and costal cartilage are often used as autologous graft. Autologous grafts are preferred in nasal reconstruction. The aim of this study was to histopathologically examine the tissue compatibility and the effect on the stability and cartilage vitality of poly-p-dioxanone (PDS) plates. Ten adult New Zealand rabbits were used. Ten New Zealand rabbits were used. Septal and auricular cartilage sections were removed; one of the two cartilage grafts was left plain, and the other was sutured to a PDS plate. Grafts were placed into the back of the rabbits. After 12 weeks, the graft material was examined microscopically. The specimens did not cause any significant foreign body reaction. Within 3 months, a significant degree of color, stability, and stiffness was lost. Microscopically, inflammation, necrosis, and cartilage cell degeneration scores were statistically significantly lower in the grafts using PDS (P < .05), and the vascularization, collagen, and cartilage proliferation scores were found to be statistically significantly higher (P < .05). No statistically significant difference was determined in respect of the bone proliferation scores (P > .05). The use of PDS plates together with cartilage provided mechanical support to the graft. Therefore, changes that disrupt the integrity of the graft, such as inflammation, necrosis, and cartilage cell degeneration, were reduced, and changes that provide greater stability, such as vascularization, collagen, and cartilage proliferation, were increased. NA Laryngoscope, 129:E129-E134, 2019.

Design strategies and applications of nacre-based biomaterials.

Mussel derived nacre, a biological composite composed of mineralized calcium carbonate platelets and interplatelet protein components, has recently gained interest as a potential alternative ceramic material in orthopedic biomaterials, combining the integration and mechanical capabilities of calcium phosphates with increased bioactivity derived from proteins and biomolecules; however, there is limited awareness of this material's potential. Herein, we present, to our knowledge, the first comprehensive review of nacre as a biomaterial. Nacre is a highly promising yet overlooked biomaterial for orthopedic tissue engineering with great potential in a wide variety of material systems. It is our hope that publication of this article will lead to increased community awareness of the potential of nacre as a versatile, bioactive ceramic capable of improving bone tissue regeneration and will elicit increased research effort and innovation utilizing nacre.

A nanofibrous electrospun patch to maintain human mesenchymal cell stemness.

Mesenchymal stem cells (MSCs) have been extensively investigated in regenerative medicine because of their crucial role in tissue healing. For these properties, they are widely tested in clinical trials, usually injected in cell suspension or in combination with tridimensional scaffolds. However, scaffolds can largely affect the fates of MSCs, inducing a progressive loss of functionality overtime. The ideal scaffold must delay MSCs differentiation until paracrine signals from the host induce their change. Herein, we proposed a nanostructured electrospun gelatin patch as an appropriate environment where human MSCs (hMSCs) can adhere, proliferate, and maintain their stemness. This patch exhibited characteristics of a non-linear elastic material and withstood degradation up to 4 weeks. As compared to culture and expansion in 2D, hMSCs on the patch showed a similar degree of proliferation and better maintained their progenitor properties, as assessed by their superior differentiation capacity towards typical mesenchymal lineages (i.e. osteogenic and chondrogenic). Furthermore, immunohistochemical analysis and longitudinal non-invasive imaging of inflammatory response revealed no sign of foreign body reaction for 3 weeks. In summary, our results demonstrated that our biocompatible patch favored the maintenance of undifferentiated hMSCs for up to 21 days and is an ideal candidate for tridimensional delivery of hMSCs. The present work reports a nanostructured patch gelatin-based able to maintain in vitro hMSCs stemness features. Moreover, hMSCs were able to differentiate toward osteo- and chondrogenic lineages once induces by differentiative media, confirming the ability of this patch to support stem cells for a potential in vivo application. These attractive properties together with the low inflammatory response in vivo make this patch a promising platform in regenerative medicine.

Socket Preservation with d-PTFE Membrane: Histologic Analysis of the Newly Formed Matrix at Membrane Removal.

This study aimed to evaluate the efficacy of an exposed high-density polytetrafluoroethylene (d-PTFE) membrane in preventing epithelial migration in postextraction sockets. For this purpose, a histologic description of the newly formed soft tissue underlying the membrane is presented. The periodontal status of the adjacent teeth was also evaluated to assess the gingival response. Ten premolar extraction sockets were treated. After tooth extraction, the sockets were filled with nanocrystalline hydroxyapatite and covered with d-PTFE membranes. Subperiosteal pockets were created to ensure the stability of the membranes. Membranes were left intentionally exposed and were atraumatically removed after 28 days. At that time, a bioptic specimen of the newly formed soft tissue under the membranes was taken. All the histologic samples showed a dense connective tissue without epithelial cells and no signs of foreign body reaction. No significant variation of the periodontal indices was observed on the teeth adjacent to the extraction sites. The study results indicate that exposed d-PTFE membranes can prevent epithelial migration in healing sockets without consequences on the periodontal health.

Fundamental biomaterial properties of tough glycosaminoglycan-containing double network hydrogels newly developed using the molecular stent method.

The purpose of this study was to clarify fundamental mechanical properties and biological responses of the sodium hyaluronate-containing double network (HA-DN) gel and chondroitin sulfate-containing double network (CS-DN) gel, which were newly developed using the molecular stent method. This study discovered the following facts. First, these hydrogels had high mechanical performance comparable to the native cartilage tissue, and the mechanical properties were not affected by immersion in the saline solution for 12weeks. Secondly, the mechanical properties of the CS-DN gel were not significantly reduced at 12weeks in vivo, while the mechanical properties of the HA-DN gel were significantly deteriorated at 6weeks. Thirdly, the degree of inflammation around the HA-DN gel was the same as that around the negative control. The CS-DN gel showed a mild but significant foreign body reaction, which was significantly greater than the negative control and less than the positive control at 1week, while the inflammation was reduced to the same level as the negative control at 4 and 6weeks. Fourthly, these gels induced differentiation of the ATDC5 cells into chondrocytes in the culture with the insulin-free maintenance medium. These findings suggest that these tough hydrogels are potential biomaterials for future application to therapeutic implants such as artificial cartilage. The present study reported fundamental biomaterial properties of the sodium hyaluronate-containing double network (HA-DN) gel and chondroitin sulfate-containing double network (CS-DN) gel, which were newly developed using the molecular stent method. Both the HA- and CS-DN gels had high mechanical properties comparable to the cartilage tissue and showed the ability to induce chondrogenic differentiation of ATDC5 cells in vitro. They are potential biomaterials that may meet the requirements of artificial cartilage concerning the material properties. Further, these DN gels can be also applied to the implantable inducer for cell-free cartilage regeneration therapy.

Optimization of alginate purification using polyvinylidene difluoride membrane filtration: Effects on immunogenicity and biocompatibility of three-dimensional alginate scaffolds.

Sodium alginate is an effective biomaterial for tissue engineering applications. Non-purified alginate is contaminated with protein, lipopolysaccharide, DNA, and RNA, which could elicit adverse immunological reactions. We developed a purification protocol to generate biocompatible alginate based on (a) activated charcoal treatment, (b) use of hydrophobic membrane filtration (we used hydrophobic polyvinylidene difluoride membranes to remove organic contaminants), (c) dialysis, and finally (d) ethanol precipitation. Using this approach, we could omit pre-treatment with chloroform and significantly reduce the quantities of reagents used. Purification resulted in reduction of residual protein by 70% down to 0.315 mg/g, DNA by 62% down to 1.28 µg/g, and RNA by 61% down to less than 10 µg/g, respectively. Lipopolysaccharide levels were reduced by >90% to less than 125 EU/g. Purified alginate did not induce splenocyte proliferation invitro. Three-dimensional scaffolds generated from purified alginate did not elicit a significant foreign body reaction, fibrotic overgrowth, or macrophage infiltration 4 weeks after implantation. This study describes a simplified and economical alginate purification method that results in alginate purity, which meets clinically useful criteria.

Selective laser-melted fully biodegradable scaffold composed of poly(d,l-lactide) and β-tricalcium phosphate with potential as a biodegradable implant for complex maxillofacial reconstruction: In vitro and in vivo results.

Scaffolds (SC) composed of poly(d,l-lactide) and β-tricalcium phosphate of variable pore structures were manufactured by selective laser melting (SLM), which allowed the production of porous interconnected structures promoting cellular adhesion and vascular proliferation. Biocompatibility, rate of osseointegration and new bone formation (NB) were analyzed. Powder based on the material composition was selective melted by a laser beam allowing layer-by-layer production. Pore size and biocompatibility were tested with mesenchymal stem cells (rMSC) and Saos 2 cells that were cultivated on SCs showing better proliferation, without toxicity, than controls. SCs with a 600- to 700-µm pore diameter proved ideal for fast and reliable cellular and vascular supply throughout the interconnecting pore system. Jaw and calvarial critical-size defects (CSD) with diameters of 5 or 16 mm were drilled in rats and either SLM test SCs (pore diameter 600 µm) or the previously removed autologs bone as controls were (re-) implanted. The SC in vivo led to complete bone ingrowth with minimal inflammatory reaction adjacent to and within the CSD as compared with controls. The SC promoted the differentiation of rMSC into osteoblasts, revealing osteoinductive properties. Promising NB ingrowth of the material was also obtained in the animal study. The SC showed complete bony replacement within 30 days in all rats; this ingrowth was significantly superior to that of controls and revealed no signs of significant foreign body reaction. Because of continuous replacement by bone this material composition is ideal for SCs fitting 3D bone defects. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1216-1231, 2017.

Stable fixation with absorbable sutures in craniofacial surgery.

The present study analyses the exclusive use of absorbable suture material (Vicryl(®), Ethicon, Germany) in the fixation of transposed bone segments in craniofacial surgery without modification of the osteotomy design. Among 129 children up to 24 months of age, osteosynthesis was conducted exclusively with Vicryl(®) sutures. The stability of postoperative results was evaluated and possible foreign body reactions were examined within the framework of clinical and radiological routine checks. All examined children exhibited stable postoperative conditions while the length of hospital stay was not affected. X-ray examinations of the skull in two planes demonstrated good bony union in all cases. Relevant foreign body reactions were not observed. The exclusive application of absorbable suture material enables stable and cost effective osteosynthesis. Significant foreign body reactions were not observed. The exclusive use of absorbable sutures did not alter the osteotomy design.

Evaluation of the biological tolerability of the starch-based medical device 4DryField® PH in vitro and in vivo a rat model.

To evaluate in vitro cytotoxicity/biocompatibility as well as in vivo tolerability of the novel polysaccharide 4DryField® PH, certified for haemostasis and adhesion prevention. In vitro cytotoxicity/viability testing according to ISO EN 10,993 using murine and human tumour cell lines incubated with 4DryField® PH (PlantTec Medical GmbH). Using a rat model the impact of 4DryField® PH on animals viability and in vivo effects were macro- and micropathologically assessed. In vitro testing revealed no cytotoxic effect of 4DryField® PH nor enhancement of viability to tumour cell lines. In vivo viability of rats was unimpaired by 4DryField® PH. Bodyweight loss in animals with abdominal injury plus treatment with 4DryField® PH was in the range of controls and less than in injured rats without treatment. At day 7 after surgery no formation of adhesions, neither macroscopic nor histological remnants nor signs of foreign body reaction were present in animals without injury. In animals with peritoneal injury and 4DryField® PH application, histopathological observation revealed minor residuals of polysaccharide in the depth of wound cavity embedded in a thickened subperitoneal layer; however, with a suggested intact neoperitoneum. The presence of mononuclear cells surrounding polysaccharide particles in varying states of degradation was observable as well. 4DryField® PH is not cytotoxic and does not enhance viability of tumour cell lines. High dose of 4DryField® PH of 1.09 g/kg bodyweight is well tolerated and reduces weight loss in animals with peritoneal injury. The biocompatibility of 4DryField® PH can be rated as being excellent.

Can bone apposition predict the retention force of a femoral stem? An experimental weight-bearing hip-implant model in goats.

BackgroundThe increasing incidence of prosthesis revision surgery in the Western world has led to an increased focus on the capacity for stem removal. We previously reported on a femoral stem implanted in goats with an approximate 15% reduction in retention force by drilling longitudinally orientated grooves on the side of the stem. In this current study, we aimed to histologically evaluate the bony apposition towards this stem and correlate this apposition with the pullout force.MethodsWe analyzed the femora of 22 goats after stem removal. All stems remained in place for 6 months, and the goats were allowed regular loading of the hip during this time. For histological evaluation, all femora were immersed in EDTA and decalcified until sufficiently soft for standard technique preparation. We evaluated bone apposition, the presence of foreign particle debris and other factors. The apposition was evaluated with a scoring system based on semi-quantitative bone apposition in four quadrants. Kappa statistics were calculated for the score. We correlated the retention force with the amount of bone apposition.ResultsThe stem drilling was the only significant factor influencing the retention force (p = 0.020). The bone apposition Kappa score comparing poor and good apposition scores was fair (κ = 0.4, 95% CI 0.00–0.88). Signs of foreign body reaction were noted in 5 of 22 goats.ConclusionsBased on the current findings in an experimental goat model, it appears that the effect of drilling tissue/bone out of the longitudinal grooves has a more significant impact on the retention force required to remove the stem than the amount of bone apposition outside the stem grooves. This observation may be further explored in the research of stem designs that are potentially easier to remove.

Antienflamatuar and antiadhesive effect of clioquinol

Backgrounds/aimsThe aim of this study is to investigate the expected adhesion-modifying effect of clinoquinol which has metal-chelating feature that limits the inflammation and fibroblastic activity. MethodsA total of 40 Wistar Albino rats were included, which were divided into 5 groups. Group-1 constituted the sham group. Other groups, adhesions were induced by performing cecal abrasion on the rats. For treatment, saline solution was added to Group-2, carboxymethylcellulose was added to Group-3, methylene blue was added to Group-4, and clioquinol was added to Group-5. Blood samples were obtained from the heart to measure IL-10 and TNF α-levels. Adhesions were evaluated both macroscopically and histopathologically. ResultsClioquinol reduced adhesions at significant level via decreasing the inflammation and fibroblastic activity in the adhesion-induced rats. At macroscopic level, carboxymethylcellulose and clioquinol were the most potent agents in reducing adhesions. Nonetheless, significant foreign body-reaction was observed in the carboxymethylcellulose-treated group. ConclusionsClioquinol could reduce the formation of intra-abdominal adhesions. It exerts this activity by limiting the inflammation and fibroblastic activity between the intestines and serous surfaces. Furthermore, it does not induce a foreign body reaction. Due to these properties, we conclude that clioquinol can be used as an alternative agent to prevent adhesions.

Ultrasonically assisted anchoring of biodegradable implants for chevron osteotomies - clinical evaluation of a novel fixation method.

Reconstructive osteotomies for the treatment of Hallux valgus are among the most prevalent procedures in foot and ankle surgery. The combination of biodegradable materials with an innovative method for fixation by application of ultrasonic energy facilitates a new bonding method for fractures or osteotomies. As clinical experience is still limited, the aim of this study was to assess the safety and performance of the SonicPin system for fixation of Austin/Chevron osteotomies. Chevron osteotomy was performed on 30 patients for the treatment of Hallux valgus. The used SonicPins were made from polylactide and are selectively melted into the cancellous bone structure during insertion by ultrasonic energy. Patients were followed for one year, which included X-ray and MRI examinations as well as evaluation of life quality by EQ-5D (EuroQol). The MRI after three months showed adequate bone healing in all cases and no signs of foreign body reactions, which was again confirmed by MRI 12 months postoperatively. The bony healing after 12 months was uneventful without any signs of foreign body reactions. In summary, based on the low complication rate and the significant improvement in health related quality of life (EQ-5D) reported in this study, fixation of an Austin/Chevron osteotomy with a SonicPin for treatment of Hallux valgus can be considered to be safe and efficient over the short term. Level of Clinical Evidence: Therapeutic Level III.

Foreign body reaction associated with PET and PET/chitosan electrospun nanofibrous abdominal meshes.

Electrospun materials have been widely explored for biomedical applications because of their advantageous characteristics, i.e., tridimensional nanofibrous structure with high surface-to-volume ratio, high porosity, and pore interconnectivity. Furthermore, considering the similarities between the nanofiber networks and the extracellular matrix (ECM), as well as the accepted role of changes in ECM for hernia repair, electrospun polymer fiber assemblies have emerged as potential materials for incisional hernia repair. In this work, we describe the application of electrospun non-absorbable mats based on poly(ethylene terephthalate) (PET) in the repair of abdominal defects, comparing the performance of these meshes with that of a commercial polypropylene mesh and a multifilament PET mesh. PET and PET/chitosan electrospun meshes revealed good performance during incisional hernia surgery, post-operative period, and no evidence of intestinal adhesion was found. The electrospun meshes were flexible with high suture retention, showing tensile strengths of 3 MPa and breaking strains of 8–33%. Nevertheless, a significant foreign body reaction (FBR) was observed in animals treated with the nanofibrous materials. Animals implanted with PET and PET/chitosan electrospun meshes (fiber diameter of 0.71±0.28 µm and 3.01±0.72 µm, respectively) showed, respectively, foreign body granuloma formation, averaging 4.2-fold and 7.4-fold greater than the control commercial mesh group (Marlex). Many foreign body giant cells (FBGC) involving nanofiber pieces were also found in the PET and PET/chitosan groups (11.9 and 19.3 times more FBGC than control, respectively). In contrast, no important FBR was observed for PET microfibers (fiber diameter = 18.9±0.21 µm). Therefore, we suggest that the reduced dimension and the high surface-to-volume ratio of the electrospun fibers caused the FBR reaction, pointing out the need for further studies to elucidate the mechanisms underlying interactions between cells/tissues and nanofibrous materials in order to gain a better understanding of the implantation risks associated with nanostructured biomaterials.