Polyethylene Glycol Hydrogel Spinal Sealant (DuraSeal Spinal Sealant) as an Adjunct to Sutured Dural Repair in the Spine

Kim, Kee D.; Wright, Neill M.

doi:10.1097/brs.0b013e3181fdb4db

Cited by 112 publications

(81 citation statements)

References 15 publications

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“…The granulation/abscess tissue formation observed in the fibrin glue-treated incisions indicated ongoing biological repair, which was not observed to the same extent on the side sealed with PEG hydrogel. 1,5,6,10,18 No significant abscess formation was found in the fibrin glue-sealed incisions in this study. Adequate blood supply is very important for accelerating wound healing and preventing postoperative infection.…”

Section: Granulation/abscess Formation In the Cerebral Cortex And Cormentioning

confidence: 45%

Comparative study of fibrin and chemical synthetic sealant on dural regeneration and brain damage

Itō¹,

Horiuchi²,

Oyanagi³

et al. 2013

SPI

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Object Several materials, such as polyethylene glycol (PEG) hydrogel and fibrin glue, have been used to seal dural incisions after brain and spinal surgeries. Although the use of PEG sealant is gaining popularity, it can be associated with postoperative cerebrospinal fluid leakage and infection. However, the reasons for this association are currently unknown. The present study aimed to investigate the effects of PEG sealant and fibrin glue on wound healing and brain damage in vivo. Methods Oval-shaped bone defects and dural defects were created bilaterally over the parietal lobes of 22 Japanese white rabbits. The dural defects were covered with 0.5 ml of fibrin glue on one side and 0.5 ml of PEG sealant on the other side. Dural regeneration and brain damage were investigated in each harvested brain and dura mater using light microscopy. Results Dural regeneration was more effective in the presence of fibrin glue than it was with PEG sealant (p = 0.014). Of the 22 rabbits, 11 showed thick (Grades ++ and +++) dural regeneration by 28 days postsurgery in the hemisphere where fibrin glue was used, whereas Grade +++ dural regeneration was not observed in the PEG hydrogel hemisphere, and only 4 rabbits showed Grade ++ regeneration. Abscess and granulation formation also tended to be more severe when PEG hydrogel sealant was used. No Grade ++ granulation/abscess formation was observed with fibrin glue, and Grade + was only observed in 13 of 22 rabbits. Conversely, with PEG hydrogel sealant, only 2 rabbits did not show granulation/abscess formation, and Grade +, ++, and +++ granulation/abscess formation was observed in 8, 7, and 5 rabbits, respectively. The extent of cortical damage was significantly greater in rabbits with abscesses and granulations, compared with rabbits without these lesions (p = 0.007). Conclusions Dural regeneration tended to occur more rapidly with fibrin glue, whereas granulation was more likely with PEG hydrogel sealant, which led to postoperative complications. Histological analysis indicated that PEG hydrogel sealant inhibited the normal tissue healing process and that outcomes were improved by the use of fibrin glue.

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Section: Granulation/abscess Formation In the Cerebral Cortex And Cormentioning

confidence: 45%

Comparative study of fibrin and chemical synthetic sealant on dural regeneration and brain damage

Itō¹,

Horiuchi²,

Oyanagi³

et al. 2013

SPI

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“…Cerebrospinal fluid leakage leads to increased morbidity, prolongation of hospital stay, surgical revision, and enhanced costs as well as possible surgical revisions. 15,19 The incidence of CSF leakage is reported to depend on the location of surgery (for example, more likely in the posterior fossa)15 but may also depend on the size of the craniotomy and dural opening or on patient-related factors such as immune status, age, or the underlying pathological process. Dural closure is usually achieved with an intended watertight suture and the addition of hemostyptic or hemostatic agents such as fibrin glue or cellulose collections.…”

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confidence: 99%

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confidence: 99%

“…15 Dural sealants have been described to be safe when used in combination with autologous dural substitute material. 8,19,35 However, there is no consensus on a standardization of dural closure, and only a few clinical studies assessed outcomes of various closure methods in a randomized and controlled manner. Kim and Wright 19 and Osbun et al 25 prospectively assessed the addition of polyethylene glycol hydrogel sealant (DuraSeal, Covidien) in spinal and cranial surgery for dural closure in comparison with standard techniques that included various dural augmentation methods according to the surgeon's choice.…”

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confidence: 99%

“…In the spinal study, intraoperative water tightness was significantly better with DuraSeal. 19 In recent years, TachoSil (Takeda Pharma), a ready-to-use, fixed combination of a collagen sponge coated with a dry layer of the biologically active human coagulation factors fibrinogen and thrombin, was introduced into the market and was used mainly as a hemostatic agent in visceral, thoracic, gynecological, and urological surgery. 9,13,16,17,[29][30][31] In liver surgery, TachoSil was superior to argon-beam laser hemostasis in a controlled parallel group trial.…”

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Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

Hütter

Felten²,

Sailer³

et al. 2014

JNS

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W hile performing cranial surgery, it is of utmost importance to achieve a tight and reliable closure of the dura mater. Cerebrospinal fluid leakage leads to increased morbidity, prolongation of hospital stay, surgical revision, and enhanced costs as well as possible surgical revisions. 15,19 The incidence of CSF leakage is reported to depend on the location of surgery (for example, more likely in the posterior fossa)15 but may also depend on the size of the craniotomy and dural opening or on patient-related factors such as immune status, age, or the underlying pathological process. Dural closure is usually achieved with an intended watertight suture and the addition of hemostyptic or hemostatic agents such as fibrin glue or cellulose collections.2,4,12 Several studies have described the use of sealants as useful in avoiding CSF leakage in supratentorial, 4,20,28,33 Object. Cerebrospinal fluid leakage is an immanent risk of cranial surgery with dural opening. Recognizing the risk factors for this complication and improving the technique of dural closure may reduce the associated morbidity and its surgical burden. The aim of this paper was to investigate whether the addition of TachoSil on top of the dural suture reduces postoperative CSF leakage compared with dural suturing alone and to assess the frequency and risk factors for dural leakage and potentially related complications after elective craniotomy.Methods. The authors conducted a prospective, randomized, double-blinded single-center trial in patients undergoing elective craniotomy with dural opening. They compared their standard dural closure by running suture alone (with the use of a dural patch if needed) to the same closure with the addition of TachoSil on top of the suture. The primary end point was the incidence of CSF leakage, defined as CSF collection or any open CSF fistula within 30 days. Secondary end points were the incidence of infection, surgical revision, and length of stay in the intensive care unit (ICU) or intermediate care (IMC) unit. The site of craniotomy, a history of diabetes mellitus, a diagnosis of meningioma, the intraoperative need of a suturable dural substitute, and blood parameters were assessed as potential risk factors for CSF leakage.Results. The authors enrolled 241 patients, of whom 229 were included in the analysis. Cerebrospinal fluid leakage, mostly self-limiting subgaleal collections, occurred in 13.5% of patients. Invasive treatment was performed in 8 patients (3.5%) (subgaleal puncture in 6, lumbar drainage in 1, and surgical revision in 1 patient). Diabetes mellitus, a higher preoperative level of C-reactive protein (CRP), and the intraoperative need for a dural patch were positively associated with the occurrence of the primary end point (p = 0.014, 0.01, and 0.049, respectively). Cerebrospinal fluid leakage (9.7% vs 17.2%, OR 0.53 [95% CI 0.23-1.15], p = 0.108) and infection (OR 0.18 [95% CI 0.01-1.18], p = 0.077) occurred less frequently in the study group than in the control group. TachoSil significantly reduc...

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Engineering the Regenerative Microenvironment with Biomaterials

Rice¹,

Martino²,

Laporte³

et al. 2012

Adv Healthcare Materials

347

310

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Modern synthetic biomaterials are being designed to integrate bioactive ligands within hydrogel scaffolds for cells to respond and assimilate within the matrix. These advanced biomaterials are only beginning to be used to simulate the complex spatio-temporal control of the natural healing microenvironment. With increasing understanding of the role of growth factors and cytokines and their interactions with components of the extracellular matrix, novel biomaterials are being developed that more closely mimic the natural healing environments of tissues, resulting in increased efficacy in applications of tissue repair and regeneration. Herein, the important aspects of the healing microenvironment, and how these features can be incorporated within innovative hydrogel scaffolds, are presented.

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Polyethylene Glycol Hydrogel Spinal Sealant (DuraSeal Spinal Sealant) as an Adjunct to Sutured Dural Repair in the Spine

Cited by 112 publications

References 15 publications

Comparative study of fibrin and chemical synthetic sealant on dural regeneration and brain damage

Comparative study of fibrin and chemical synthetic sealant on dural regeneration and brain damage

Risk factors for postoperative CSF leakage after elective craniotomy and the efficacy of fleece-bound tissue sealing against dural suturing alone: a randomized controlled trial

Engineering the Regenerative Microenvironment with Biomaterials

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