Effects of New Anti-Adhesion Polyvinyl Alcohol Gel on Healing of Colon Anastomoses in Rats

Slieker, Juliette; Ditzel, Max; Harlaar, Joris Jan; Mulder, Irene M.; Deerenberg, Eva B.; Bastiaansen-Jenniskens, Y.M.; Kleinrensink, Gert-Jan; Jeekel, J; Lange, Johan F.

doi:10.1089/sur.2011.114

Cited by 7 publications

(8 citation statements)

References 30 publications

(37 reference statements)

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“…The promising efficacy demonstrated by the A-Part Ò hydrogel in this experiment stimulated us to investigate this product further, focusing on its safety when applied around an intestinal anastomosis and in the presence of synthetic material such as intra-abdominally placed meshes [33]. The promising experimental results also led to initiation of a clinical trial of the safety and efficacy of the hydrogel [34].…”

Section: Discussionmentioning

confidence: 91%

Polyvinyl Alcohol Hydrogel Decreases Formation of Adhesions in a Rat Model of Peritonitis

Deerenberg

Mulder

Ditzel

et al. 2012

Surgical Infections

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Section: Discussionmentioning

confidence: 91%

Polyvinyl Alcohol Hydrogel Decreases Formation of Adhesions in a Rat Model of Peritonitis

Deerenberg

Mulder

Ditzel

et al. 2012

Surgical Infections

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“…Furthermore, it could be shown that there was no difference in tissue qualities regarding tensiometry-induced tissue rupture comparing test and control groups; however, once more splenomegaly was identified in the rabbit end-to-end anastomosis model, being related to phagocytosis of the PVA/CMC material. In contrast to rats [30,31,32,33], rabbits seem to be more sensitive to resorption and excretion of PVA/CMC gel. Therefore, the rabbit abdominal wall model as well as the rabbit anastomosis model treated with PVA/CMC gel indicate a limited and adjusted dosage before internal use, suggesting a dosage <2 ml PVA/CMC gel per kg body weight per rabbit and indicating the necessity of a careful adjustment of the dosage in human clinical studies as well.…”

Section: Discussionmentioning

confidence: 95%

“…Medical devices, such as adhesion-preventing agents, must fulfill extensive requirements regarding biocompatibility, safety and efficacy before their admission into common practice [[35], FDA Guidance for resorbable adhesion barrier devices for the use in abdominal and/or pelvic surgery: guidance for industry]. Different study groups have shown the positive anti-adhesion properties of PVA/CMC membranes and gels in different and complex animal models [32,33,37]. Despite the fact that PVA and CMC are commonly used substances for topological medical use, little is known about their internal reactions in the body, although the clearance of PVA out of the body has been described accurately [38].…”

Section: Discussionmentioning

confidence: 99%

“…Previously, a significant reduction of postoperative adhesion was recorded for PVA/CMC in rats [30,32], rabbits [27,29] and pigs [31], making the material suitable for consideration as an adhesion-prevention agent for hernia meshes. Fujino et al [39] used a 1.5 × 1.5 cm polypropylene mesh directly on the intact peritoneum of rabbits.…”

Section: Discussionmentioning

confidence: 99%

“…In addition to promising results regarding functional efficiency, PVA/CMC gel or membrane has been demonstrated to have both the physical and chemical properties necessary to support their use as an adhesion-prevention barrier [26,27,28]. In this case, PVA/CMC gel formed a stable as well as elastic barrier that could be easily and effectively applied [29,30,31] and that yielded a resorption half-life of about 2 weeks, a period that allows sufficient time for the most critical phase of wound healing to occur [32,33]. …”

Section: Introductionmentioning

confidence: 99%

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Standard Biocompatibility Studies Do Not Predict All Effects of PVA/CMC Anti-Adhesive Gel in vivo

Freytag¹,

Odermatt²

2016

Eur Surg Res

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Purpose: PVA/CMC (polyvinyl alcohol/carboxymethyl cellulose) hydrogel fulfills various physiochemical properties required for an adhesion barrier and has shown good anti-adhesion properties in previous in vivo studies. In this investigation, we assessed the in vitro and in vivo biocompatibility of PVA/CMC gel and compared this to the functionality and promotion of wound healing for two surgical indications. Methods: Standardized ISO10993 in vitro and in vivo biocompatibility studies, comprising cytotoxicity, genotoxicity, acute systemic toxicity, delayed contact and maximization sensitization test, intracutaneous reactivity and local muscle implantation, were performed on PVA/CMC gel. In the functional studies, PVA/CMC gel was applied - on the one hand - to a rabbit abdominal wall model enforced with a polypropylene mesh for testing the anti-adhesion properties and - on the other hand - to an end- to-end anastomosis model that was selected for surveying potential influences of different dosages of PVA/CMC gel on anastomotic wound healing. Results: The ISO10993 methods indicated generally good biocompatibility properties, such as the absence of cytotoxic and mutagenic effects as well as no signs of systemic toxicity and sensitization potentials. No irritation effects were observed after the intracutaneous injection of lipophilic PVA/CMC sesame oil extract. However, the injection of hydrophilic PVA/CMC physiologic saline extract induced slight irritation. Following rabbit muscle implantation of the PVA membrane for 2, 4, 12, 26 and 52 weeks, a slight irritant effect was observed at 12 weeks due to the peak of phagocytosis. In the functionality tests, PVA/CMC gel showed good anti-adhesive effects in the abdominal wall model enforced with the mesh, with significantly lower and less tense adhesions compared to the untreated control. However, moderate signs of inflammation, especially in the spleen were observed after the intra-abdominal implantation of 3.3 ml PVA/CMC gel per kg body weight. In the end-to-end anastomosis model, PVA/CMC gel had no influence on wound healing. For dosages of 1-6 ml gel per treatment, no signs of intestinal leaks were detected, and tensile strength was equal to that of the untreated control, but again more moderate signs of inflammation in the spleen were observed at a dosage >3 ml. Conclusion: Comparing the standardized ISO10993 methods, anti-adhesive PVA/CMC gel displays good biocompatibility. However, those methods do not seem to be sensitive enough because the rabbit abdominal wall and the end-to-end anastomosis models display more effects with respect to the dosage and routes of the intra-abdominal resorption of PVA/CMC gel - with the recommended <2 ml PVA/CMC gel per kg body weight as a secure dosage.

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Polymers for Surgery

Suzuki

Ikada

2014

Advanced Polymers in Medicine

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Effects of New Anti-Adhesion Polyvinyl Alcohol Gel on Healing of Colon Anastomoses in Rats

Abstract: This experimental study showed no significant differences in anastomotic leakage, anastomotic bursting pressure, or collagen content of the anastomosis when using the adhesion barrier polyvinyl alcohol around colonic anastomoses. The barrier did not prevent adhesion formation.

Cited by 7 publications

References 30 publications

Polyvinyl Alcohol Hydrogel Decreases Formation of Adhesions in a Rat Model of Peritonitis

Polyvinyl Alcohol Hydrogel Decreases Formation of Adhesions in a Rat Model of Peritonitis

Standard Biocompatibility Studies Do Not Predict All Effects of PVA/CMC Anti-Adhesive Gel in vivo

Polymers for Surgery

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