Fixation of polyvinylidene fluoride (PVDF) mesh with cyanoacrylate-derived glues in a rat experimental model: histopathologic immunohistochemical and morphometric study
“…6 ). Glubran 2 is, in fact, not associated with foreign body reactions [ 20 ], and it does not compromise the healing process [ 24 ]. Fig.…”
Section: Resultsmentioning
confidence: 99%
“…Similarly, Glubran 2, a biocompatible acrylic sealant constituted by the two N-butyl-2-cyanoAcrylate and methacryloxy-sulfolane monomers (manufactured by GEM S.r.l., Viareggio Italy), is currently vastly used thanks to its hemostatic properties, fast action and adhesive strength [19]; this sealant polymerizes in 1-2 seconds to 1 minute when in contact with tissues, generating a tight transparent film that is permeable to oxygen but not to liquids [20]. Its efficacy has been tested mainly in preclinical animal studies: Glubran 2 showed to be useful for the neuroradiological endovascular treatment of fistulas and AVMs [21] and management of possible complications arising during the embolization of aneurysms [22]; it also demonstrated to be successful as an innovative strategy for mesh fixation following surgical abdominal hernia repair [23][24][25][26]. Glubran efficacy has not only been demonstrated on animal tissues, but also directly on humans: the first preliminary experiences were collected on a pediatric sample subjected to laparoscopic endosurgery [20].…”
Background
Endoscopic Submucosal Dissection (ESD) is the treatment of choice of superficial neoplastic gastrointestinal lesions. Delayed bleedings and perforations are still current clinical concerns. Glubran 2 is a synthetic cyanoacrylate-derived glue nowadays already widely used as an effective tissue adhesive. ENDONEB is a novel device thought for enabling the sealant nebulization over a specific targeted surface during laparotomy, laparoscopy, and thoracotomy. The aim of this single-center preclinical animal trial is to evaluate the feasibility and safety of the same nebulization technique during ESD in the perspective that further clinical studies would demonstrate the efficacy of Glubran 2 in preventing post-ESD adverse events.
Methods
Four live Landrace pigs were enrolled. Two approximately 30-mm-wide gastric ESDs were performed in each pig (experimental ESD and control ESD). About 0.5 mL of Glubran 2 was nebulized on the experimental ESDs. Subjective perception of the feasibility of the Glubran 2 nebulization was reported. Pigs were clinically monitored at follow-up and upper GI endoscopy was performed at 24 and 48 hours, when animals were euthanized to perform a macroscopic and histological analysis of the specimens.
Results
No peri-procedural adverse events were reported. Glubran 2 nebulization over experimental ESDs showed to be technically easy and time-effective. Clinical and endoscopic animal monitoring was negative at follow-up. At 24 hours, the Glubran 2 film was clearly visible on the eschar of the ESDs and signs of initial hydrolysis were discernable at 48 hours. No signs of peritoneal reaction were observed at the macroscopic examination. Equal transmural inflammation was described at the histological examination of both types of ESDs.
Conclusions
Safety and feasibility profiles of Glubran 2 nebulizing ENDONEB device over ESD surfaces were excellent. Further evidences and human trials are needed to investigate its effectiveness in ESDs’ eschars sealing and, thus, in delayed micro-perforations and bleedings prevention and treatment.
“…6 ). Glubran 2 is, in fact, not associated with foreign body reactions [ 20 ], and it does not compromise the healing process [ 24 ]. Fig.…”
Section: Resultsmentioning
confidence: 99%
“…Similarly, Glubran 2, a biocompatible acrylic sealant constituted by the two N-butyl-2-cyanoAcrylate and methacryloxy-sulfolane monomers (manufactured by GEM S.r.l., Viareggio Italy), is currently vastly used thanks to its hemostatic properties, fast action and adhesive strength [19]; this sealant polymerizes in 1-2 seconds to 1 minute when in contact with tissues, generating a tight transparent film that is permeable to oxygen but not to liquids [20]. Its efficacy has been tested mainly in preclinical animal studies: Glubran 2 showed to be useful for the neuroradiological endovascular treatment of fistulas and AVMs [21] and management of possible complications arising during the embolization of aneurysms [22]; it also demonstrated to be successful as an innovative strategy for mesh fixation following surgical abdominal hernia repair [23][24][25][26]. Glubran efficacy has not only been demonstrated on animal tissues, but also directly on humans: the first preliminary experiences were collected on a pediatric sample subjected to laparoscopic endosurgery [20].…”
Background
Endoscopic Submucosal Dissection (ESD) is the treatment of choice of superficial neoplastic gastrointestinal lesions. Delayed bleedings and perforations are still current clinical concerns. Glubran 2 is a synthetic cyanoacrylate-derived glue nowadays already widely used as an effective tissue adhesive. ENDONEB is a novel device thought for enabling the sealant nebulization over a specific targeted surface during laparotomy, laparoscopy, and thoracotomy. The aim of this single-center preclinical animal trial is to evaluate the feasibility and safety of the same nebulization technique during ESD in the perspective that further clinical studies would demonstrate the efficacy of Glubran 2 in preventing post-ESD adverse events.
Methods
Four live Landrace pigs were enrolled. Two approximately 30-mm-wide gastric ESDs were performed in each pig (experimental ESD and control ESD). About 0.5 mL of Glubran 2 was nebulized on the experimental ESDs. Subjective perception of the feasibility of the Glubran 2 nebulization was reported. Pigs were clinically monitored at follow-up and upper GI endoscopy was performed at 24 and 48 hours, when animals were euthanized to perform a macroscopic and histological analysis of the specimens.
Results
No peri-procedural adverse events were reported. Glubran 2 nebulization over experimental ESDs showed to be technically easy and time-effective. Clinical and endoscopic animal monitoring was negative at follow-up. At 24 hours, the Glubran 2 film was clearly visible on the eschar of the ESDs and signs of initial hydrolysis were discernable at 48 hours. No signs of peritoneal reaction were observed at the macroscopic examination. Equal transmural inflammation was described at the histological examination of both types of ESDs.
Conclusions
Safety and feasibility profiles of Glubran 2 nebulizing ENDONEB device over ESD surfaces were excellent. Further evidences and human trials are needed to investigate its effectiveness in ESDs’ eschars sealing and, thus, in delayed micro-perforations and bleedings prevention and treatment.
“…Those studies showed that cyanoacrylate remained in the tissue for an extended period and that its efficacy persisted. 8 -11 Espin Alvarez et al described cyanoacrylate as more durable than synthetic sutures in gastrostomy closures in their experimental porcine study 8. Those authors also reported that the histopathological and inflammatory variables were similar in both groups.…”
Introduction: To study the efficiency of internal compression therapy (ICT), a new and promising method of treatment for deep venous insufficiency, how that efficiency is achieved, and its potential side-effects, in a porcine model. Material and Methods: The femoral vein diameters of 4 pigs were first measured. ICT was then applied such as to reduce the diameter of these veins by 50%. The femoral vein diameters of 2 pigs were re-measured after 1 month. The femoral vein and its surrounding tissue were excised for immunohistopathological and genetic examination. The same procedures were applied to the remaining 2 pigs 3 months subsequently. Collagen I and IV immunohistochemical staining and Masson’s trichrome and Alcian blue histochemical staining were applied during immunohistopathological examination. Collagen I, III, and IV and connective tissue growth factor (CTGF) mRNA expressions were examined for genetic examination. Results: The femoral vein diameters decreased by approximately 50% after ICT application. This decrease persisted after the first and third months. Histopathological examination revealed loose connective tissue around the venous tissue after the operation, particularly in the third month, together with perivascular fibrosis and increased collagen in connective tissue. No difference was observed between regions with and without ICT application in terms of mucinous degeneration, an indicator of tissue injury, during Alcian blue staining. Genetic examination revealed an increase in collagen I and IV and CTGF mRNA expression in perivascular tissue resulting from ICT application. Conclusion: ICT is effective both in terms of creating a durable tissue around the vein and of increasing collagen tissue and stimulating fibrosis, and has no deleterious side-effects on tissue.
“…Экспериментальные исследования подтвердили, что тканевые адгезивы на основе цианоакрилатов дают хорошую инкорпорацию синтетических имплантатов в ткани пациента при низкой частоте осложнений и невыраженной острой тканевой реакции. Через 30 дней после операции не отмечалось признаков отрыва или смещения имплантатов, которые были фиксированы плотной оформленной соединительной тканью, богатой волокнами коллагена I типа [24].…”
The article provides a detailed description of methods and devices for fixation mesh implants used for ventral hernia repair. An illustrated description of the implant fixation technique for laparoscopic IPOM surgery is given.
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