Dataset Information

Ex vivo evaluation of a multilayered sealant patch for watertight dural closure: cranial and spinal models.

ABSTRACT: Cerebrospinal fluid leakage is a frequent complication after cranial and spinal surgery. To prevent this complication and seal the dura watertight, we developed Liqoseal, a dural sealant patch comprising a watertight polyesterurethane layer and an adhesive layer consisting of poly(DL-lactide-co-ε-caprolactone) copolymer and multiarmed N-hydroxylsuccinimide functionalized polyethylene glycol. We compared acute burst pressure and resistance to physiological conditions for 72 h of Liqoseal, Adherus, Duraseal, Tachosil, and Tisseel using computer-assisted models and fresh porcine dura. The mean acute burst pressure of Liqoseal in the cranial model (145 ± 39 mmHg) was higher than that of Adherus (87 ± 47 mmHg), Duraseal (51 ± 42 mmHg) and Tachosil (71 ± 16 mmHg). Under physiological conditions, cranial model resistance test results showed that 2 of 3 Liqoseal sealants maintained dural attachment during 72 hours as opposed to 3 of 3 for Adherus and Duraseal and 0 of 3 for Tachosil. The mean burst pressure of Liqoseal in the spinal model (233 ± 81 mmHg) was higher than that of Tachosil (123 ± 63 mmHg) and Tisseel (23 ± 16 mmHg). Under physiological conditions, spinal model resistance test results showed that 2 of 3 Liqoseal sealants maintained dural attachment for 72 hours as opposed to 3 of 3 for Adherus and 0 of 3 for Duraseal and Tachosil. This novel study showed that Liqoseal is capable of achieving a strong watertight seal over a dural defect in ex vivo models.

SUBMITTER: Kinaci A

PROVIDER: S-EPMC8302489 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:PurposeCerebrospinal fluid (CSF) leakage is a challenging complication of intradural cranial surgery, and children are particularly at risk. The use of dural sealants confers protection in adults, but pediatric studies are scarce. We evaluated the safety and efficacy of Evicel® fibrin sealant as an adjunct to primary dural suturing in children undergoing cranial surgery.MethodsA multicenter trial prospectively enrolled pediatric subjects (< 18 years) undergoing cranial neurosurgery who, upon completion of primary sutured dural repair, experienced CSF leakage. As agreed by the EMA Evicel® Pediatric Investigation Plan, 40 subjects were intra-operatively randomized 2:1 to Evicel® or additional sutures ('Sutures'). Data analysis was descriptive. The efficacy endpoint was treatment success rate, with success defined as intra-operative watertight closure after provocative Valsalva maneuver (primary endpoint). Safety endpoints were postoperative CSF leakage (incisional CSF leakage, pseudomeningocele or both) and surgical site complications (secondary endpoints).ResultsForty subjects (0.6-17 years) were randomized to Evicel® (N = 25) or Sutures (N = 15) (intention-to-treat). Intracranial tumor was the most common indication and procedures were mostly supratentorial craniotomies. Success rates were 92.0% for Evicel® and 33.3% for Sutures, with a 2.76 estimated ratio of success rates (Farrington-Manning 95% CI [1.53, 6.16]). Sensitivity analyses in per-protocol and safety sets showed similar results. Despite a higher rescue treatment rate, the frequencies of postoperative CSF leakage and wound complications were higher for Sutures than for Evicel®.ConclusionThis small-scale prospective study shows Evicel® treatment to be safe and effective as an adjunct to primary sutured dura mater closure in a pediatric population. Compared to additional sutures, Evicel® was associated with reduced postoperative CSF leakage and surgical site complications. (Trial registration: The trial was registered as NCT02309645 and EudraCT 2013-003558-26).

Project description:BackgroundWound closure is a key, and often underrecognized, component of hip and knee arthroplasty. Methods for wound closure are an important consideration to better avoid wound-related adverse events; however, there is a lack of consensus on optimal methods. The objective of the following review was twofold: to characterize the wound closure methods used by layer in the total knee arthroplasty and total hip arthroplasty literature and summarize optimal wound-healing strategies to address the risk of adverse events.MethodsA systematic literature review was performed to identify total knee arthroplasty and total hip arthroplasty randomized controlled trials and nonrandomized studies reporting wound closure methods by layer and wound-healing adverse events (including superficial, deep, or periprosthetic joint infections, wound dehiscence, or prolonged wound drainage). Studies on revision procedures were excluded. Wound closure methods and adverse events were summarized qualitatively as meta-analyses were not possible because of study heterogeneity.ResultsForty studies met the inclusion criteria: 22 randomized controlled trials and 18 observational studies. Across studies, 6 categories and 22 unique techniques for closure were identified. Conventional closure methods exhibited large ranges of adverse event rates. Studies of multilayer barbed sutures with topical skin adhesives and polyester mesh or multilayer antimicrobial sutures reported narrow ranges of adverse events rates.ConclusionsConsiderable variability exists for wound closure methods, with a wide range reported in adverse events. Recent technologies and methods for standardized watertight, multilayer closure show promise for avoiding adverse events and unnecessary health-care costs; however, higher quality, comparative studies are required to enable future meta-analyses.Level of evidenceTherapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Dataset Information

Ex vivo evaluation of a multilayered sealant patch for watertight dural closure: cranial and spinal models.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets