Histological analysis of DuraGen in a human subject: case report

Khorasani, L.; Kapur, Raj P.; Lee, C.; Avellino, Anthony M.

doi:10.5414/npp27361

Cited by 11 publications

(10 citation statements)

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“…DGX is cleared by FDA as a dural substitute for the repair of dura mater for which clinical acceptability and biocompatibility characteristics have been established. 14 , 15 DGX was applied dry then moistened with saline followed by digital pressure for 2 min with dry gauze.…”

Section: Methodsmentioning

confidence: 99%

Safety and Efficacy of a Novel, Self-Adhering Dural Substitute in a Canine Supratentorial Durotomy Model

et al. 2017

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BACKGROUNDCerebrospinal fluid (CSF) leaks increase postoperative risk for complication, likelihood of reoperation, and costs.OBJECTIVETo investigate a novel, self-adhering polyethylene glycol-coated collagen pad (PCC) as a dural substitute relative to Duragen XS (DGX; Integra LifeSciences Corporation, Plainsboro, New Jersey) and as a dural sealant relative to Tachosil (Takeda Austria GmbH, Linz, Austria), a fibrinogen and thrombin-coated collagen pad (FTC).METHODSA canine supratentorial durotomy surgical model was used to investigate the safety and efficacy of PCC. For safety, 4 animals were bilaterally treated with DGX or PCC and recovered for 1, 8, or 16 wk; total 24 animals. Each animal underwent physical and neurological examinations weekly and 16-wk animals underwent a magnetic resonance imaging (MRI) examination at each time point. For efficacy, 9 animals were unilaterally treated with FTC or PCC and underwent a burst pressure test intraoperatively or 14 d postoperatively; total 36 animals.RESULTSIn the safety study, no abnormal clinical signs or changes were noted on physical and neurological examinations, or in clinical pathology, CSF analysis or histopathology of DGX or PCC-treated animals. No consistent signs of cerebral compression, CSF leak, hemorrhage, or hydrocephalus were noted on MRI. In the efficacy study, no significant difference was found between FTC and PCC at each time point or overall (13.9 vs 12.3 mm Hg, n = 18 per group, P = .46).CONCLUSIONPCC is safe for use as a dural substitute and effective as a dural sealant. The novel, self-adhering combination of a polyethylene glycol-based sealant and a collagen pad may offer unique benefits to the advancement of duraplasty.

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Section: Methodsmentioning

confidence: 99%

Safety and Efficacy of a Novel, Self-Adhering Dural Substitute in a Canine Supratentorial Durotomy Model

et al. 2017

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“…Second, the collagen matrix has large pores that can facilitate broblastic ingrowth, resulting in neomembrane formation [9,15,16]. In this study, neomembrane formation accompanied by neovascularization was also demonstrated on postoperative MRI (Fig.…”

Section: Discussionmentioning

confidence: 59%

Modified Shoelace Dural Closure With Collagen Matrix in Extended Transsphenoidal Surgery

Nagata¹,

Takeuchi²,

Sasaki³

et al. 2021

Preprint

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Extended endonasal transsphenoidal surgery (eTSS) offers a wide surgical field for various parasellar lesions; however, intraoperative high-flow cerebrospinal fluid (CSF) leakage is inevitable. Therefore, secure sellar reconstruction methods are essential to prevent postoperative CSF leakage. Although collagen matrix has been applied for dural reconstruction in neurosurgery, its suitability for application in extended eTSS remains unclear.Fifteen patients underwent modified shoelace dural closure using collagen matrix after lesionectomy via extended eTSS. In this technique, a collagen matrix, which was placed subdurally (inlay graft), was continuously sutured with both open dural edges like a shoelace. Then, another collagen matrix was placed epidurally (onlay graft), and rigid reconstruction was performed using the septal bone and a resorbable fixation mesh. Postoperative CSF leakage did not occur in fourteen patients, but did in one patient with tuberculum sellae meningioma. In this case, the CSF leakage point was detected just around the area between the coagulated dura and the adjacent collagen matrix. The collagen matrix harvested from this area was pathologically examined; neovascularization and fibroblastic infiltration into the collagen matrix were not detected. On the other hand, neovascularization and fibroblast infiltration into the collagen matrix were apparent on the surface of the collagen matrix harvested from the non-CSF leakage area.Our novel dural closure technique using collagen matrix could be an effective option for sellar reconstruction in extended eTSS; however, it should be applied in patients in whom normal dural edges are preserved.Clinical trial registrationNot applicable

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“…The development of postoperative scar tissue and adhesions is a natural consequence of healing, but can be associated with general medical and reoperation complications. Many biocompatible products have been evaluated as barriers or deterrents to adhesions [8][9][10].…”

Section: Discussionmentioning

confidence: 99%