Safety and efficacy of a novel polyethylene glycol hydrogel sealant for watertight dural repair

Cosgrove, G. Rees; Delashaw, Johnny B.; Grotenhuis, J. André; Tew, John M.; Loveren, Harry van; Spetzler, Robert F.; Payner, Troy D.; Rosseau, Gail; Shaffrey, Mark E.; Hopkins, L. Nelson; Byrne, Richard W.; Norbash, Alexander

doi:10.3171/jns.2007.106.1.52

Cited by 142 publications

(113 citation statements)

References 35 publications

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“…Boogarts et al [2] reported no evidence of postapplication cerebrospinal fluid leaks or adverse events in 46 patients who had a spontaneous dural tear treated with DuraSeal TM . Cosgrove et al [5] reported similar findings with no evidence of postapplication cerebrospinal fluid leaks in 95.5% of patients and no adverse events with the use of DuraSeal TM . After these reports, the use of DuraSeal TM was extended as an adjunct to suture closure of an iatrogenic dural tear.…”

Section: Discussionsupporting

confidence: 63%

Cauda Equina Syndrome After a TLIF Resulting From Postoperative Expansion of a Hydrogel Dural Sealant

Neuman

Radcliff

Rihn

2012

Clinical Orthopaedics &Amp; Related Research

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Background DuraSeal TM (Coviden, Waltham, MA, USA), a hydrogel sealant, is primarily used as an adjunct to a dural repair. Its use has also been described to seal off an annulotomy after a transforaminal lumbar interbody fusion when recombinant human bone morphogenetic protein-2 (rhBMP-2) is used. This aids in the reduction of postoperative radiculitis caused by rhBMP-2. However, as a result of its hydrophilic properties, DuraSeal TM has the potential to swell, which could lead to compression of the thecal sac. Case Description We report a 57-year-old woman who developed cauda equina after a transforaminal lumbar 47 interbody fusion (TLIF) procedure in which the expansion of the DuraSeal TM was believed to be the causative factor. The patient developed urinary retention, bowel incontinence, and paresthesias in the saddle region on postoperative Day 3. She underwent emergent exploration and decompression of the thecal sac. The gel-like DuraSeal TM material was causing significant compression of the thecal sac. Literature Review Multiple reports have documented that DuraSeal TM , used as an adjunct to dural repair, can swell leading to compression of the spinal cord and/or neural elements. Our case demonstrates the use of DuraSeal TM both over a site of a dural repair and over an annulotomy site, through which a TLIF was performed, is associated with the risk of developing postoperative cauda equina syndrome as a result of swelling of the DuraSeal TM . Clinical Relevance Those using DuraSeal TM to seal off the annulotomy after a TLIF procedure performed with rhBMP-2 should use the product with an understanding of the potential postoperative swelling of the product and resulting neurologic sequela, particularly if DuraSeal TM is used concomitantly at the site of dural repair.

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Section: Discussionsupporting

confidence: 63%

Cauda Equina Syndrome After a TLIF Resulting From Postoperative Expansion of a Hydrogel Dural Sealant

Neuman

Radcliff

Rihn

2012

Clinical Orthopaedics &Amp; Related Research

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“…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.…”

mentioning

confidence: 99%

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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“…2,3,[14][15][16] This hydrogel sealant system can also be used to seal dural defects. Polyethylene glycol hydrogel sealant is a chemical synthetic sealant formed by mixing PEG ester solution and trilysine amine solution.…”

mentioning

confidence: 99%

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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Safety and efficacy of a novel polyethylene glycol hydrogel sealant for watertight dural repair

Abstract: The PEG hydrogel sealant provides a safe and effective watertight closure when used as an adjunct to sutured dural repair during cranial surgery.

Cited by 142 publications

References 35 publications

Cauda Equina Syndrome After a TLIF Resulting From Postoperative Expansion of a Hydrogel Dural Sealant

Cauda Equina Syndrome After a TLIF Resulting From Postoperative Expansion of a Hydrogel Dural Sealant

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

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

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