Evaluation of a Novel Absorbable Mesh in a Porcine Model of Abdominal Wall Repair.
Ontology highlight
ABSTRACT: Methods
Two full-thickness defects were created in the abdominal walls of nine Yucatan swine via midline approach and repaired preperitoneally with either DuraSorb or long-lasting control mesh (TIGR, Novus Scientific). At 30 days, 3 months, and 1 year, the implantations were assessed by clinical pathology, post-necropsy histopathology, and burst strength testing.Results
No device-associated complications were found in vivo, at necropsy, or histologically. DuraSorb was well-integrated and vascularized by 30 days. DuraSorb demonstrated minimal/mild inflammation and fibroplasia, and lower inflammatory scores when compared with TIGR at all time points (P < 0.05). Burst strength of the repair sites was higher than adjacent abdominal wall at all time points (P < 0.05).Conclusions
DuraSorb provided durable long-term support, minimal inflammation, and consistent absorption in this porcine model of abdominal wall repair, as compared to a long-term control. Clinical data is needed, but these results suggest that this mesh provides adequate structural support while potentially reducing long-term device reactions.
SUBMITTER: Mlodinow AS
PROVIDER: S-EPMC8647887 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:BACKGROUND:The objective of this study was to evaluate the mechanical and histological properties of a fully absorbable poly-4-hydroxybutyrate/absorbable barrier composite mesh (Phasix™ ST) compared to partially absorbable (Ventralight™ ST), fully absorbable (Phasix™), and biologically derived (Strattice™) meshes in a porcine model of ventral hernia repair. METHODS:Bilateral abdominal surgical defects were created in twenty-four Yucatan pigs, repaired with intraperitoneal (Phasix™ ST, Ventralight™ ST) or retromuscular (Phasix™, Strattice™) mesh, and evaluated at 12 and 24 weeks (n = 6 mesh/group/time point). RESULTS:Prior to implantation, Strattice™ demonstrated significantly higher (p < 0.001) strength (636.6 ± 192.1 N) compared to Ventralight™ ST (324.3 ± 37.1 N), Phasix™ ST (206.9 ± 11.3 N), and Phasix™ (200.6 ± 25.2 N). At 12 and 24 weeks, mesh/repair strength was significantly greater than NAW (p < 0.01 in all cases), and no significant changes in strength were observed for any meshes between 12 and 24 weeks (p > 0.05). Phasix™ mesh/repair strength was significantly greater than Strattice™ (p < 0.001) at 12 and 24 weeks, and Ventralight™ ST mesh/repair strength was significantly greater than Phasix™ ST mesh (p < 0.05) at 24 weeks. At 12 and 24 weeks, Phasix™ ST and Ventralight™ ST were associated with mild inflammation and minimal-mild fibrosis/neovascularization, with no significant differences between groups. At both time points, Phasix™ was associated with minimal-mild inflammation/fibrosis and mild neovascularization. Strattice™ was associated with minimal inflammation/fibrosis, with minimal neovascularization at 12 weeks, which increased to mild by 24 weeks. Strattice™ exhibited significantly less neovascularization than Phasix™ at 12 weeks and significantly greater inflammation at 24 weeks due to remodeling. CONCLUSIONS:Phasix™ ST demonstrated mechanical and histological properties comparable to partially absorbable (Ventralight™ ST) and fully resorbable (Phasix™) meshes at 12 and 24 weeks in this model. Data also suggest that fully absorbable meshes with longer-term resorption profiles may provide improved mechanical and histological properties compared to biologically derived scaffolds.
| S-EPMC4992027 | biostudies-literature
Project description:ObjectiveAbdominal wall hernias are common abdominal diseases, and effective hernia repair is challenging. In clinical practice, synthetic meshes are widely applied for repairing abdominal wall hernias. However, postoperative complications, such as inflammation and adhesion, are prevalent. Although biological meshes can solve this problem to a certain extent, they face the problems of heterogeneity, rapid degradation rate, ordinary mechanical properties, and high-cost. Here, a novel electrospinning mesh composed of polylactic acid and silk fibroin (PLA-SF) for repairing abdominal wall hernias was manufactured with good physical properties, biocompatibility and low production cost.Materials and methodsFTIR and EDS were used to demonstrate that the PLA-SF mesh was successfully synthesized. The physicochemical properties of PLA-SF were detected by swelling experiments and in vitro degradation experiments. The water contact angle reflected the hydrophilicity, and the stress‒strain curve reflected the mechanical properties. A rat abdominal wall hernia model was established to observe degradation, adhesion, and inflammation in vivo. In vitro cell mesh culture experiments were used to detect cytocompatibility and search for affected biochemical pathways.ResultsThe PLA-SF mesh was successfully synthesized and did not swell or degrade over time in vitro. It had a high hydrophilicity and strength. The PLA-SF mesh significantly reduced abdominal inflammation and inhibited adhesion formation in rat models. The in vitro degradation rate of the PLA-SF mesh was slower than that of tissue remodeling. Coculture experiments suggested that the PLA-SF mesh reduced the expression of inflammatory factors secreted by fibroblasts and promoted fibroblast proliferation through the TGF-β1/Smad pathway.ConclusionThe PLA-SF mesh had excellent physicochemical properties and biocompatibility, promoted hernia repair of the rat abdominal wall, and reduced postoperative inflammation and adhesion. It is a promising mesh and has potential for clinical application.
| S-EPMC10767193 | biostudies-literature
Project description:Complex abdominal wall defects (CAWDs) can be difficult to repair and using a conventional synthetic mesh is often unsuitable. A biological mesh might offer a solution for CAWD repair, but the clinical outcomes are unclear. Here, we evaluated the efficacy of a cross-linked, acellular porcine dermal collagen matrix implant (Permacol) for CAWD repair in a cohort of 60 patients. Here, 58.3% patients presented with a grade 3 hernia (according to the Ventral Hernia Working Group grading system) and a contaminated surgical field. Permacol was implanted as a bridge in 46.7%, as an underlay (intraperitoneal position) in 38.3% and as a sublay (retromuscolar position) in 15% of patients. Fascia closure was achieved in 53.3% of patients. The surgical site occurrence rate was 35% and the defect size significantly influenced the probability of post-operative complications. The long-term (2 year) hernia recurrence rate was 36.2%. This study represents the first large multi-centre Italian case series on Permacol implants in patients with a CAWD. Our data suggest that Permacol is a feasible strategy to repair a CAWD, with acceptable early complications and long-term (2 year) recurrence rates.
| S-EPMC7042221 | biostudies-literature
Project description:The purpose of this study is to evaluate the histologic response to fibrin sealant (FS) as an alternative fixation method for laparoscopic ventral hernia repair.One non-absorbable barrier mesh (Composix™) and three absorbable barrier meshes (Sepramesh™, Proceed™, and Parietex™ Composite) were used for the study, with uncoated macroporous polypropylene mesh (ProLite Ultra™) as the control. Three methods of fixation were used: #0-polypropylene suture + FS (ARTISS™, Baxter Healthcare Corp.), FS alone (ARTISS™), or tacks alone (n = 10 for each group). Two pieces of mesh (of dimensions 4 × 4-cm) were secured intraperitoneally in 75 New Zealand white rabbits. After 8 weeks, hematoxylin and eosin (H&E)-stained specimens were evaluated for host tissue response. Statistical significance (P < 0.05) was determined using a one-way analysis of variance (ANOVA) with Fisher's least significant difference (LSD) post hoc test.Composix™ with FS only showed significantly greater cellular infiltration than with suture + FS (P = 0.0007), Proceed™ with FS only had significantly greater neovascularization than with suture + FS (P = 0.0172), and ProLite Ultra™ with suture + FS had significantly greater neovascularization than with tacks only (P = 0.046). Differences due to mesh type showed that Composix™ exhibited less extensive cellular infiltration (P ? 0.0032), extracellular matrix (ECM) deposition, and neovascularization, and demonstrated less inflammatory cells and more fibroblasts compared to the other meshes (P < 0.05).FS did not have a significant histologic effect compared to tacks when utilized for the fixation of mesh to the peritoneum of New Zealand White rabbits. However, the mesh type did have a significant histologic effect. The permanent barrier mesh (Composix™) was associated with less histologic incorporation than absorbable barrier and macroporous meshes, as evidenced by lower levels of cellular infiltration, ECM deposition, and neovascularization, independent of the fixation method used.
| S-EPMC3826828 | biostudies-literature
Project description:BackgroundTraumatic abdominal wall hernias or defects (TAWDs) after blunt trauma are rare and comprehensive literature on this topic is scarce. Altogether, there is no consensus about optimal methods and timing of repair, resulting in a surgeon's dilemma. The aim of this study was to analyze current literature, comparing (1) acute versus delayed repair and (2) mesh versus no mesh repair.MethodsA broad and systematic search was conducted in PubMed, EMBASE, and the Cochrane Library. The selected articles were assessed on methodological quality using a modified version of the CONSORT 2010 Checklist and the Newcastle-Ottawa scale. Primary endpoint was hernia recurrence, diagnosed by clinical examination or CT. Random effects meta-analyses on hernia recurrence rates after acute versus delayed repair, and mesh versus no mesh repair, were conducted separately.ResultsIn total, 19 studies were evaluated, of which 6 were used in our analysis. These studies reported a total of 229 patients who developed a TAWD, of whom a little more than half underwent surgical repair. Twenty-three of 172 patients (13%) who had their TAWD surgically repaired developed a recurrence. In these studies, nearly 70% of the patients who developed a recurrence had their TAWD repaired primarily without a mesh augmentation and mostly during the initial hospitalization. Pooled analysis did not show any statistically significant favor for either use of mesh augmentation or the timing of surgical repair.ConclusionAlthough 70% of the recurrences occurred in patients without mesh augmentation, pooled analysis did not show significant differences in either mesh versus no mesh repair, nor acute versus delayed repair for the management of traumatic abdominal wall defects. Therefore, a patient's condition (e.g., concomitant injuries) should determine the timing of repair, preferably with the use of a mesh augmentation.
| S-EPMC6918711 | biostudies-literature
Project description:BackgroundAchieving stable closure of complex or contaminated abdominal wall incisions remains challenging. This study aimed to characterise the stage of innovation for bioabsorbable mesh devices used during both midline closure prophylaxis and complex abdominal wall reconstruction and to evaluate the quality of current evidence.MethodsA systematic review of published and ongoing studies was performed until 31st December 2019. Inclusion criteria were studies where bioabsorbable mesh was used to support fascial closure either prophylactically after midline laparotomy or for repair of incisional hernia with midline incision. Exclusion criteria were: (1) study design was a systematic review, meta-analysis, letter, review, comment, or conference abstract; (2) included less than p patients; (3) only evaluated biological, synthetic or composite meshes. The primary outcome measure was the IDEAL framework stage of innovation. The key secondary outcome measure was the risk of bias in non-randomised studies of interventions (ROBINS-I) criteria for study quality.ResultsTwelve studies including 1287 patients were included. Three studies considered mesh prophylaxis and nine studies considered hernia repair. There were only two published studies of IDEAL 2B. The remainder was IDEAL 2A studies. The quality of the evidence was categorised as having a risk of bias of a moderate, serious or critical level in nine of the twelve included studies using the ROBINS-I tool.ConclusionThe evidence base for bioabsorbable mesh is limited. Better reporting and quality control of surgical techniques are needed. Although new trial results over the next decade will improve the evidence base, more trials in emergency and contaminated settings are required to establish the limits of indication.
| S-EPMC7867504 | biostudies-literature
Project description:PurposeComplex abdominal wall hernia repair (CAWHR) is a challenging procedure. Mesh prosthesis is indicated, but the use of synthetic mesh in a contaminated area may add to overall morbidity. Biological meshes may provide a solution, but little is known about long-term results. The aim of our study was to evaluate clinical efficacy and patient satisfaction following Strattice™ (PADM) placement.MethodsIn this cohort study, all patients operated for CAWHR with PADM in three large community hospitals in Germany were included. Patients underwent abdominal examination, an ultrasound was performed, and patients completed quality-of-life questionnaires. The study was registered in ClinicalTrials.gov under Identifier NCT02168231.ResultsTwenty-seven patients were assessed (14 male, age 67.5 years, follow-up 42.4 months). The most frequent postoperative complication was wound infection (39.1%). In no case, the PADM had to be removed. Four patients had passed away. During outpatient clinic visit, six out of 23 patients (26.1%) had a recurrence of hernia, one patient had undergone reoperation. Five patients (21.7%) had bulging of the abdominal wall. Quality-of-life questionnaires revealed that patients judged their scar with a median 3.5 out of 10 points (0 = best) and judged their restrictions during daily activities with a median of 0 out of 10.0 (0 = no restriction).ConclusionsDespite a high rate of wound infection, no biological mesh had to be removed. In some cases, therefore, the biological meshes provided a safe way out of desperate clinical situations. Both the recurrence rate and the amount of bulging are high (failure rate 47.8%). The reported quality of life is good after repair of these complex hernias.
| S-EPMC7272387 | biostudies-literature
Project description:INTRODUCTION:Reticular hybrid meshes represent an alternative material for intraperitoneal repair of abdominal hernias. These consist of a reticular mesh coated or interwoven/knitted with inert materials. This study assesses the performance of two reticular polypropylene-containing hybrid meshes, TiMESH (coated with titanium) and DynaMesh (interwoven with polyvinylidene fluoride), in vitro, as well as their efficiency in adhesion prevention and tissue incorporation in an intraperitoneal model. METHODS:The mesothelialization capacity of TiMESH and DynaMesh was evaluated in vitro and compared to that of Surgipro (reticular bare polypropylene) and Preclude (laminar expanded polytetrafluoroethylene). Mesh fragments were placed on the intact parietal peritoneum of New Zealand white rabbits (n = 24), and laparoscopy performed 7 days post-surgery. Fourteen days post-implantation, adhesions were evaluated and host tissue incorporation, macrophage response, collagen expression (immunohistochemistry/RT-PCR) and neoperitoneum formation assessed. Adhesions and omental tissue were also examined. RESULTS:Mesh pores in reticular meshes were devoid of cells in the in vitro study. TiMESH, DynaMesh and Surgipro showed similar adhesion rates at 7/14 days and optimal tissue integration, with significant differences in comparison to Preclude. The greatest presence of macrophages was observed for TiMESH and was significant versus that for Preclude. Hybrid meshes revealed significantly higher collagen 1 mRNA expression in implants, with no differences in the levels of collagen 3. Omental samples from animals with a reticular mesh showed significantly greater collagen 1 mRNA levels. CONCLUSIONS:The reticular structure of a mesh limits the formation of a continuous mesothelial monolayer in vitro, regardless of its composition. The presence of titanium as a coating or polyvinylidene fluoride interwoven with polypropylene in a reticular structure did not prevent adhesions. The hybrid meshes showed proper integration and an increase in the mRNA Col 1 levels in the implant area compared to Surgipro or Preclude.
| S-EPMC6392302 | biostudies-literature
Project description:Hypertrophic scars found on the human body rarely develop in experimental animals, possibly due to their looser skin structure. This makes it difficult to understand the genesis of scar lesions. Therefore, appropriate animal models are urgently needed. In this study, we established a novel experimental model of a scar-forming wound by resecting a small portion of the abdominal muscle wall on the lower center of the abdomen in C57BL/6N mice, which are exposed to contractive forces by the surrounding muscle tissue. As a low-tension control, a back skin excision model was used with a splint fixed onto the excised skin edge, and granulation tissue formed on the muscle fascia supported by the back skeleton. One week after the resection, initial healing reactions, such as fibroblast proliferation, occurred in both models. However, after 21 days, lesions with collagen-rich granulation tissues, which were also accompanied by multiple nodular/spherical-like structures, developed only in the abdominal wall model. These lesions were analogous to scar lesions in humans. Therefore, the animal model developed in this study is unique in that fibrous scar tissues form under physiological conditions without using any artificial factors and is valuable for studying the pathogenesis and preclinical treatment of scar lesions.
| S-EPMC8762401 | biostudies-literature
Project description:PurposeTo compare the safety and efficacy of an absorbable inferior vena cava (IVC) filter and a benchmark IVC filter in a porcine model.Materials and methodsA randomized controlled Good Laboratory Practice study was performed in Domestic Yorkshire cross swine. Sixteen swine were implanted with an absorbable IVC filter (test device; Adient Medical, Pearland, Texas); 8 were implanted with a benchmark metal IVC filter (control device; Cook Medical, Bloomington, Indiana). All animals underwent rotational digital subtraction pulmonary angiography and cavography (anteroposterior and lateral) before filter deployment and 5 and 32 weeks after deployment. Terminal procedures and necropsy were performed at 32 weeks. The IVC, heart, lungs, liver, and kidneys were harvested at necropsy. The reported randomized controlled GLP animal study was conducted at Synchrony Labs, Durham, North Carolina.ResultsOne animal died early in the test cohort of a recurring hemorrhage at the femoral access site resulting from a filter placement complication. All other animals remained clinically healthy throughout the study. No pulmonary embolism was detected at the 5- and 32-week follow-up visits. The absorbable filter subjects experienced less caval wall perforation (0% vs 100%) and thrombosis (0% vs 75%). The control device routinely perforated the IVC and occasionally produced collateral trauma to adjacent tissues (psoas muscle and aorta). The veins implanted with the absorbable filter were macroscopically indistinguishable from normal adjacent veins at 32 weeks except for the presence of radiopaque markers. Nontarget tissues showed no device-related changes.ConclusionsImplantation of the absorbable IVC filter in swine proved safe with no pulmonary emboli detected. There was complete to near-complete resorption of the filter polymer by 32 weeks with restoration of the normal appearance and structure of the IVC.
| S-EPMC6736596 | biostudies-literature