Sealant System Research Articles

Is the BioSentry Tract Sealant System Effective in Reducing the Pneumothorax Rate After CT-Guided Transthoracic Lung Biopsy With an 18G Biopsy Needle?

This study evaluated whether the BioSentry Tract Sealant System (BTS) (Merit Medical Systems, South Jordan, Utah) reduces pneumothorax rates in CT-guided lung biopsies (CTLB) using an 18G biopsy/17G introducer needle. A total of 272 patients underwent CTLB between January 2015 and February 2019 using a 17G/18G system. BTS was used in 125 patients, while no pleural sealant was used in 147. The variables assessed included pneumothorax on post-biopsy CT images or chest X-ray, chest tube insertion, lesion size, pleura-to-lesion distance, and the presence of emphysema. The two groups were compared using T-tests with a significance level of 0.05. In the BTS group, 23 subjects (18%) had a pneumothorax compared to 38 (26%) in the control group (p < 0.05). Four patients (17%) in the BTS group required a chest tube, compared to three patients (8%) in the control group (p = 0.28). The mean lesion size in patients with a pneumothorax was 1.62 cm in the BTS group and 2.44 cm in the control group (p = 0.27). The mean pleura-to-lesion distance in those with pneumothorax was 2.23 cm in the BTS group and 1.52 cm in the control group (p = 0.17). Emphysema was present in 47% of patients in the BTS group and 30% in the control group (p < 0.05). BTS reduced pneumothorax rates in CTLB patients using a 17G/18G system, despite a higher proportion of emphysema patients in the BTS group. No significant difference in the rate of chest tube insertion was observed with or without BTS, which contrasts with previous studies where 19G/20G biopsy systems were used.

Postoperative Thoracic Cord Compression Induced by a Dural Sealant System (DuraSeal®): A Case Report and Literature Review

Cerebrospinal fluid (CSF) leakage is a rare complication that can occur due to dural defects during spinal surgery, hindering the improvement of the surgical site and increasing the possibility of infection. DuraSeal® is a dural sealing adhesive that prevents CSF leakage and is used as an adjunct to enable the watertight repair of dural defects when the dura is damaged during spinal surgery. In the present case, DuraSeal® was applied to repair a dural defect in the surgical area after thoracic spine surgery, and no neurological problems occurred immediately after surgery. However, a day later, the patient’s paraparesis worsened; therefore, reoperation was performed and the symptoms improved.

Moisture- and mould-resistance: multi-modal modelling leveraging X-ray tomography in edge-sealed cross-laminated timber

Edge-sealing, which involves treating the edges of wood products, improves water resistance. This study investigated the feasibility of edge-sealed cross-laminated timber (CLT) panels to reduce capillary water uptake, thereby resisting mould formation. The water and vapour permeabilities of ten characteristically different single-layer sealant coating systems were systematically determined. Multi-modal assessment leveraged by computed tomography (CT) scanning methodology was used to enhance detection of material characteristics beyond the standard coating permeability assessment. Moisture content was observed to change during the specimens’ absorption and desorption depending on the sealant system applied. The results revealed different characteristics of coatings during the water absorption and desorption stages. Findings from this study were used to develop recommendations regarding the water resistance of coating systems, curing time, susceptibility to mould formation, and industrial applicability. Results suggest that edge-sealed CLT could minimise the risk of mould formation, which can occur at worksites with minimal weather protection. The method developed in this study provides a basis to evaluate new coating systems and determine which use case is the best for a particular coating type. This study also incorporates insights from industry to identify future research orientations, which may pave the way for new designs and assessment techniques.

Sphenopalatine Ganglion Block for Headache Treatment After an Incidental Durotomy: A Case Report.

Incidental durotomy is the most common intraoperative complication of spine surgeries. Our main goal is to report a case of a postoperative postdural puncture headache following an incidental durotomy successfully managed with a sphenopalatine ganglion block. A 75-year-old woman, American Society of Anesthesiologists physical status II, proposed for a lumbar interbody fusion. During surgery, an incidental durotomy with cerebrospinal fluid leak occurred, being repaired with muscle and DuraSeal® Dural Sealant System. In the recovery room, 1 hour after the end of the surgery, the patient developed a severe headache associated with nausea and photophobia. A bilateral transnasal sphenopalatine ganglion block with 0.75% ropivacaine was performed. Immediate pain relief was verified. The patient reported only mild headaches on the first postoperative day, feeling progressively better until discharge. The sphenopalatine ganglion block may be an effective alternative treatment for postdural puncture headache following an incidental durotomy during neurosurgeries. Sphenopalatine ganglion block may be a safe, lowrisk alternative in the treatment of postdural puncture headache after an incidental durotomy that can be used in the immediate postoperative period to enable early recovery and return to day-to-day activities, which will hopefully lead to better surgical outcomes and patient satisfaction.

A comparative high-resolution physicochemical analysis of commercially available fibrin sealants: Impact of sealant osmolality on biological performance.

Fibrin sealants are well-established components of the surgical toolbox, especially in procedures that harbor a high risk of perioperative bleeding. Their widespread use as hemostats, sealants or tissue-adhesives in various surgical settings has shown that the choice of the appropriate sealant system affects the clinical outcome. While many studies have compared the hemostatic efficiency of fibrin sealants to that of other natural or synthetic sealants, there is still limited data on how subtle differences in fibrin sealant formulations relate to their biological performance. Here, we performed an in-depth physicochemical and biological characterization of the two most commonly used fibrin sealants in the US and Europe: TISSEEL™ ("FS") and VISTASEAL™/VERASEAL™ ("FS+Osm"). Our chemical analyses demonstrated differences between the two sealants, with lower fibrinogen concentrations and supraphysiological osmolality in the FS+Osm formulation. Rheological testing revealed FS clots have greater clot stiffness, which strongly correlated with network density. Ultrastructural analysis by scanning electron microscopy revealed differences between FS and FS+Osm fibrin networks, the latter characterized by a largely amorphous hydrogel structure in contrast to the physiological fibrillar network of FS. Cytocompatibility experiments with human fibroblasts seeded on FS and FS+Osm fibrin networks, or cultured in presence of sealant extracts, revealed that FS+Osm induced apoptosis, which was not observed with FS. Although differential sealant osmolality and amounts of fibrinogen, as well as the presence of Factor XIII or additives such as antifibrinolytics, may explain the mechanical and structural differences observed between the two fibrin sealants, none of these substances are known to cause apoptosis at the respective concentrations in the sealant formulation. We thus conclude that hyper osmolality in the FS+Osm formulation is the primary trigger of apoptosis-a mechanism that should be evaluated in more detail, as it may affect the cellular wound healing response in situ.

Preparation of eco-friendly natural rosin-based SiO2–NH2@GO hybrid sealant and study on corrosion resistance of Fe-based amorphous coating for steel substrate

Sealing treatment is an effective method to prolong the service life of Fe-based amorphous coatings for steel substrates. Common sealants always have the disadvantages of releasing amounts of volatile organic compounds (VOC) and are expensive, prompting researchers to develop an eco-friendly, low cost and high-performance sealant. However, their simultaneous improvement is restricted by some inevitable contradictions among them. Herein, natural rosin was introduced as a sealing material and an eco-friendly natural rosin-based SiO2–NH2@GO hybrid sealant was successfully prepared by the sol-gel method. In addition, the functional nanocomposite SiO2–NH2@GO was added to the hybrid sealant system to achieve the purpose of extending the service life of the sealant. The filling efficiency, adhesion, thermal stability and long-term corrosion resistance of hybrid sealants were investigated. The study showed that the adhesion of the hybrid sealant to the Fe-based amorphous coating was improved by 10.59% after adding the nanocomposite. The hybrid sealant reaches maximum thermal decomposition at 414.3 °C. The corrosion current density (icorr) of the sample NSG-0.5‰ still decreased by about two orders of magnitude after immersion for 672 h (0#, icorr = 1.39 × 10−4 A/cm2; NSG-0.5‰, icorr = 1.51 × 10−6 A/cm2). Full immersion experiments explore the failure process of hybrid sealants, where corrosion always tends to propagate with unmelted particles. The hybrid sealant prepared has the advantages of being eco-friendly and low cost, and provides a specific preparation process, which provides a new direction for the development of the sealant.

The chemistry insight: epoxy sealant as an alternative remedial operation for well integrity

Abstract Epoxy resin is commonly used in the oil and gas industry due to its excellent toughness, low shrinkage, good adhesive strength, and relatively good thermal resistance. It is used for water shutoff, zonal isolation, cementing, enhanced oil recovery, and preventing leakage in wells. This paper reviews the chemistry aspect of using an epoxy resin system as a sealant to prevent well leakage and it offers insights into the chemistry of the epoxy resin system, as applied in previous studies. The paper also unveils the reasons for the application of this system from the chemistry perspective, allowing this aspect to be better understood. Success in the investigated cases depended on the formulation design. The epoxide and hydroxyl functional groups have been found to contribute substantially to the excellent performance of the sealant system. Furthermore, the amine curing agent triggers the abrupt reaction of the oxirane ring to stabilise when the cured sealant is perfectly applied. Based on the findings, it is suggested that other types of epoxies, namely epoxidised oils, require further study. Finally, in terms of safety and sustainable energy, it is suggested that more curing agent and diluent studies are undertaken.

A Cost-benefit Analysis of Using Polyethylene Glycol Hydrogel Sealant versus Fibrin Glue as a Dural Sealant for Posterior Fossa Surgery in the United States

Background: Cerebrospinal fluid (CSF) leaks are a well-known complication of posterior fossa neurosurgery. The use of dural repair adjuncts has been associated with fewer CSF leaks and subsequently, lower medical costs. Objectives: To determine if the use of polyethylene glycol hydrogel sealant (DuraSeal dural sealant system [DuraSeal]), resulted in cost savings in the United States compared to use of fibrin glue in posterior fossa neurosurgery based on a published study of these two products. Methods: Primary analysis was based on a published cohort study (100 patients per cohort). Adjustments were made to account for the longer follow-up time of the fibrin glue cohort to better capture the incidence of CSF leaks, pseudomeningocele, wound infection, and meningitis using additional data from the literature. Resource utilization was calculated from literature studies and confirmed with consultations from two practicing neurosurgeons. The effective time horizon was 19 months. Undiscounted Medicare payments were used to calculate unit costs from a payer’s perspective based on hospital stay, cost of sealant application, and cost of complications. One-way sensitivity analysis was used to examine changes in costs as a result of model input changes. Results: In the base case, the cost of the hospital stay for the original surgery, which excludes the cost of complications, dominated costs for both cohorts. On a per patient basis, the use of fibrin glue cost $1666 more than the use of DuraSeal. Sensitivity analysis showed that using lumbar drainage instead of operative repair for a CSF leak reduced cost savings to $680. Holding the incidence of CSF leaks constant for the fibrin glue cohort while increasing the incidence for the DuraSeal cohort by 50% or 300% resulted in cost savings of $1438 and $755, respectively. Conclusions: The results of this study demonstrate a positive, consistent cost-benefit of DuraSeal compared to fibrin glue based on a cohort study of real world patients who underwent posterior fossa neurosurgery.

Full-field shingle uplift measurements using StereoDIC: Comparison of single and double sealant three-tab shingle responses when subjected to hurricane velocity winds

For the first time, the vision-based measurement method Stereo Digital Image Correlation (StereoDIC) is applied successfully to quantitatively assess the response of asphalt shingles installed in a model roofing system and subjected to hurricane velocity winds. By mounting a low profile asphalt-shingled plywood roof facsimile without building firmly to a rigid steel frame and supplying sustained winds of 67.1 m/s perpendicular to the leading edge region, StereoDIC measurements were obtained at 1 Hz to measure the full-field uplift displacements for shingles sealed using either single or double sealant strips. By varying the sealant activation process (time and temperature), the effect of installation in winter and summer seasons is also quantified throughout the wind loading process. Results indicate that with lower temperature sealant activation, both single and double sealant shingles sustained catastrophic failure within a short time when the wind speed reached 67.1 m/s, with the double sealant system lasting for about 500 s; visual inspection of the separation surfaces for the low temperature activation showed large specular reflecting regions, indicating either no bonding or minimal adherence. For a higher sealant activation temperature, (a) both single and double sealant shingles remained intact for more than 2 h in 67.1 m/s wind speeds, with no sealant separation observed and (b) displacements for the shingle with double sealant strips were significantly lower than for the single sealant system, confirming the efficacy of a double sealant strip system. As a general observation, StereoDIC measurements clearly show that shingle uplift displacement is not constant across the width of a shingle tab, with the edges of the shingle (tab cutout regions) having significantly larger uplift displacements that may serve as sealant separation initiation sites.

175 - Use of the Biosentry tract sealant system (Angiodynamics®) for radiological marking of lung lesions as an adjunct to surgery

175 - Use of the Biosentry tract sealant system (Angiodynamics®) for radiological marking of lung lesions as an adjunct to surgery

Efficacy and safety of polyethylene glycol dural sealant system in cranial and spinal neurosurgical procedures: Meta-analysis

Background: We aimed to assess the efficacy of polyethylene glycol (PEG) dura sealant to achieve watertight closure, prevention of cerebrospinal fluid (CSF) leak and to investigate its possible side effects.Methods: We searched Medline (through PubMed), Scopus, and the Cochrane Library through December 2019. We included articles demonstrating cranial or spinal procedures with the use of PEG material as a dural sealant. Data on intraoperative watertight closure, CSF leak, and surgical complications were extracted and pooled in a meta-analysis model using RevMan version 5.3 and OpenMeta (Analyst).Results: Pooling the controlled trials showed that PEG resulted in significantly more intraoperative watertight closures than standard care (risk ratio [RR] = 1.44, 95% confidence interval [CI] [1.24, 1.66]). However, the combined effect estimate did not reveal any significant difference between both groups in terms of CSF leaks, the incidence of surgical site infections, and neurological deficits (P = 0.7, 0.45, and 0.92, respectively). On the other hand, pooling both controlled and noncontrolled trials showed significance in terms of leak and neurological complications (RR = 0.0238, 95% CI [0.0102, 0.0373] and RR = 0.035, 95% CI [0.018, 0.052]). Regarding intraoperative watertight closure, the overall effect estimate showed no significant results (RR=0.994, 95% CI [0.986, 1.002]).Conclusion: Dura seal material is an acceptable adjuvant for dural closure when the integrity of the dura is questionable. However, marketing it as a factor for the prevention of surgical site infection is not scientifically proved. We suggest that, for neurosurgeons, using the dural sealants are highly recommended for duraplasty, skull base approaches, and in keyhole approaches.

Cost Analysis: Use of Hydrogel Plug Tract Sealant System for CT-Guided Lung Biopsy can Reduce Patient Recovery Time and Cost

A total of 235 patients were analyzed for pneumothorax rates (124 patient in 3-hour recovery group and 111 patients the 1.5-hour group). Pneumothorax rate on follow-up chest radiographs was 22% vs 13% in the 3-hour vs 1.5-hour recovery groups, and chest tube insertion rate was 3.9% vs 0%, respectively. In a 30-day follow-up available in 96% of patients, the 3- and 1.5-hour groups each had 1 patient hospitalized for delayed complications but neither required chest tube placement. Discharging patients if absent or small stable pneumothorax detected on 1.5-hour post-lung biopsy recovery chest radiograph resulted in total cost savings of $686 (P < 0.05) and recovery cost savings of $487 (P < 0.001) on average per patient.

Systematic Experimental Investigation on In-Situ Self-Adaptive Sealing Property of Composite Pressure-Activated Sealant for Curing Minor Tubular Leaks

Curing minor leaks and restoring the integrity of a wellbore in a safe and economical way is always challenging in oil and gas production. In this work, a composite pressure-activated sealant, combined with liquid and solid sealing materials, was prepared via the demulsification approach. The structure, morphology, and size distribution of key particulates in the sealant were examined, and the in-situ self-adaptive sealing property was examined with a specially design dynamic sealing detector. The results indicated that the pressure-activated sealant was a multi-dispersed phase system, and the dispersed colloid particles were regular in shape and had a narrow size distribution of 300–400 μm. The solid sealing materials were introduced to construct a composite pressure-activated sealant, and the sealing capability can be markedly reinforced by cooperativity of liquid and solid sealing materials. A mechanochemical coupling model was put forward to rationalize the dynamic sealing process. Finally, such sealant system was employed in a certain offshore gas well with sustained casing pressure to verify its applicability in minor defect repairs.

Abstract No. 586 Is the Biosentry tract sealant system effective in reducing pneumothorax rate after computed tomography–guided transthoracic lung biopsy with an 18-gauge biopsy needle?

Biosentry tract sealant system (BTS) is a Food and Drug Administration–approved device that deploys a hydrogel plug to seal the pleural puncture after CT-guided transthoracic lung biopsy (CTLB). It has been shown to reduce pneumothorax (PTX) rates with a 20G biopsy-19G introducer needle. The purpose of this study is to evaluate if BTS reduces PTX rates in patients undergoing CTLB with 18G biopsy-17G introducer needle (17G/18G system). In this retrospective study, 272 patients (mean age, 69.4 years) underwent CTLB between January 2015 and February 2019 using a 17G/18G system. BTS was used in 125 patients, and no pleural sealant was used in 147. The variables assessed were PTX on postbiopsy CT images or chest x-ray, chest tube insertion, lesion size, pleura to lesion distance, and presence of emphysema. Comparison between the two groups using T-tests with a significance level set at 0.05 was performed. 23 subjects (18%) had a PTX in BTS group compared to 38 (26%) in controls (P <0.05). 4 patients (17%) required a chest tube in the BTS group, and 3 (8%) in the control (P = 0.28). Mean lesion size in those with PTX was 1.62 cm in the BTS group and 2.44 cm in controls (P = 0.27). Mean pleura to lesion distance in those with PTX was 2.23 cm in the BTS group and 1.52 cm in controls (P = 0.17). Emphysema was present in 47% of patients in the BTS group and 30% in control group (P < 0.05). BTS reduced the pneumothorax rates in CTLB patients with a 17G/18G biopsy system, despite a higher proportion of emphysema patients in BTS group compared to controls. However, the rate of chest tube insertion did not change, in contrast to previous studies in which 19G/20G biopsy systems were used. Additionally, PTX rate was not affected by lesion size or pleura to lesion distance.Table 1BTS (n = 125)Controls (n = 147)PMean/StdDevMean/StdDevPTX rate0.18/0.030.26/0.04<0.05Chest tube insertion rate0.17/0.380.08/0.270.28Lesion size in PTX subjects (cm)1.62/1.122.4/3.50.27Pleura to lesion distance in PTX subjects (cm)2.23/2.231.5/1.80.17% with Emphysema4730<0.05PTX = Pneumothorax, StdDev = Standard Deviation Open table in a new tab

03:54 PM Abstract No. 409 Impact of a pleural tract sealant system on pneumothorax rates after lung biopsy at an academic institution

Recent data has demonstrated efficacy of a pleural tract sealant system (PTSS; Biosentry) in reduction of rates of pneumothorax (PTX), chest tube placement, and admissions after lung biopsy. The purpose of this study is to compare pneumothorax rate before and after utilization of the PTSS when used in an academic institution in a high risk patient population. A retrospective cohort study was performed of all CT-guided percutaneous lung biopsies at an academic institution from July 2016 to July 2018 to include approximately one year of data before and after PTSS adoption. Exclusion criteria included non-use of PTSS after official adoption, aborted procedures, and incomplete data sets. Independent variables analyzed included age, gender, presence of emphysema, pleural passes, needle in time, lobe laterality, and segment. Primary outcome was presence of a pneumothorax on initial post-biopsy chest radiograph. Data was then analyzed in an A-priori, binary logistic model adjusted for confounders (threshold for inclusion p<0.10). There were 265 patients included in the final analysis (PTSS = 150, No PTSS = 115). Only potential confounding factor meeting inclusion threshold was emphysema (p=.001). There was no difference in the overall between group rates of PTX (13% with PTSS versus 8% without PTSS; p=0.17). Binary logistic analysis discovered a higher incidence of PTX in patients with emphysema with the use of PTSS versus no PTSS. Ultimately emphysema was identified as an independent predictor of PTX in patients in which a PTSS was used (p=.047). PTSS alone or PTSS by needle time failed to be significant independent predictors. Patients with emphysema have higher rates of PTX when using a PTSS system while patients without emphysema have lower rates of post-biopsy PTX. These results suggest that using a PTSS system may be contraindicated in patients with emphysema. Additional prospective studies will be needed.

DuraSeal Exact Is a Safe Adjunctive Treatment for Durotomy in Spine: Postapproval Study.

Study Design:A nonrandomized, two-armed prospective study.Objective:Water-tight dural closure is paramount to the prevention of cerebrospinal fluid (CSF) leakage and associated complications. Synthetic polyethylene glycol (PEG) hydrogel has been used as an adjunct to sutured dural repair; however, its expansion postoperatively is a concern for neurological complications. A low-swell formulation of PEG sealant was introduced as DuraSeal Exact Spine Sealant System (DESS). A Post-Approval Study was performed primarily to evaluate the safety and efficacy of DESS for spinal dural repair compared to current alternatives, in a large patient population, reflecting a real-world practice.Methods:A total of 36 sites in the United States enrolled 429 patients treated with DESS as an adjunct to dural repair in the spinal sealant group and 406 patients treated with all other modalities in the control arm, from October 2011 to June 2016. The primary endpoint was the incidence of CSF leak within 90 days of operation. The secondary endpoints evaluated were deep surgical site infection and neurological serious adverse events.Results:The CSF leakage in the DESS group (6.6%) was not significantly different from the control group (6.5%) (p = .83), and there was no significant difference in the time to first leak. The two groups had no significant differences in deep surgical site infection (1.6% versus control 2.1%, p = .61) or proportion of subjects with neurological serious adverse events (2.9% versus control 1.6%, p = .516).Conclusions:DuraSeal Exact Spinal Sealant is safe when compared to current alternatives for spinal dural repair.

Microencapsulation of 2,2′-Azobis(2-methylpropionamide) dihydrochloride initiator using acrylonitrile butadiene styrene as shell for application in lost-circulation control

Gel sealants are often used to recover lost circulation, a problem that plagues drilling engineers throughout many oil and gas development project. Organic cross-linked polymer gel such as cross-linked polyacrylamide gel is one of the most popular and available gel sealant materials. It is of strong sealing ability, but the gelation time is too short to control and ensure safe drilling operation. Initiator used to supply free radical can prolong polyacrylamide gelation time, but the gelation time will dramatically decline with the increase of temperature. Microencapsulation of initiator can increase the gelation time because the concentration of initiator is controlled effectively by microcapsules. This paper proposes microcapsules of an initiator, 2,2′-Azobis(2-methylpropionamide) dihydrochloride (AIBA) encapsulated by Acrylonitrile Butadiene Styrene, prolonging the gelation time of cross-linked polyacrylamide gel. It was prepared via coacervation induced by polydimethylsiloxane (PDMS). The gelation time was prolonged to be eight times greater than that initiated by free AIBA initiator. Fourier transform infrared spectroscopy, thermogravimetric analysis, Ultraviolet-visible spectroscopy, specific surface area analysis, and scanning electron microscopy were used to observe the properties of microcapsules. The results indicated that AIBA was successfully microencapsulated and there were nano-sized pores in the outer surfaces of the microcapsules which serve to control the release of AIBA, and viscosity of PDMS and core/shell ration affected the content of AIBA loaded in the microcapsules. Moreover, it is microencapsulation that makes the concentration of AIBA in water increase stable as a function of time for prolonging the gelation time of sealant system. Computerized tomography (CT) scans revealed that the cross-linked polymer gel system significantly reduces the number of pores inside the cores and enhances pressure-bearing ability. Cross-linked polyacrylamide gel initiated by encapsulated AIBA shows notable potential for recovering lost circulation.

Efficacy of Dural Sealant System for Preventing Brain Shift and Improving Accuracy in Deep Brain Stimulation Surgery.

The success of deep brain stimulation (DBS) depends heavily on surgical accuracy, and brain shift is recognized as a significant factor influencing accuracy. We investigated the factors associated with surgical accuracy and showed the effectiveness of a dural sealant system for preventing brain shift in 32 consecutive cases receiving DBS. Thirty-two patients receiving DBS between March 2014 and May 2015 were included in this study. We employed conventional burr hole techniques for the first 18 cases (Group I) and a dural sealant system (DuraSeal) for the subsequent 14 cases (Group II). We measured gaps between the actual positions of electrodes and the predetermined target positions. We then retrospectively evaluated the factors involved in surgical accuracy. The average gap between an electrode’s actual and target positions was 1.55 ± 0.83 mm in all cases. Postoperative subdural air volume e, the only factor associated with surgical accuracy (r = 0.536, P < 0.0001), was significantly smaller in Group II (Group I: 43.9 ± 27.7, Group II: 12.1 ± 12.5 ml, P = 0.0006). The average electrode position gap was also significantly smaller in Group II (Group I: 1.77 ± 0.91, Group II: 1.27 ± 0.59 mm, P = 0.035). Use of a dural sealant system could significantly reduce intracranial air volume, which should improve surgical accuracy.

A Cost-benefit Analysis of Using Polyethylene Glycol Hydrogel Sealant versus Fibrin Glue as a Dural Sealant for Posterior Fossa Surgery in the United States.

Background: Cerebrospinal fluid (CSF) leaks are a well-known complication of posterior fossa neurosurgery. The use of dural repair adjuncts has been associated with fewer CSF leaks and subsequently, lower medical costs.Objectives: To determine if the use of polyethylene glycol hydrogel sealant (DuraSeal dural sealant system [DuraSeal]), resulted in cost savings in the United States compared to use of fibrin glue in posterior fossa neurosurgery based on a published study of these two products.Methods: Primary analysis was based on a published cohort study (100 patients per cohort). Adjustments were made to account for the longer follow-up time of the fibrin glue cohort to better capture the incidence of CSF leaks, pseudomeningocele, wound infection, and meningitis using additional data from the literature. Resource utilization was calculated from literature studies and confirmed with consultations from two practicing neurosurgeons. The effective time horizon was 19 months. Undiscounted Medicare payments were used to calculate unit costs from a payer’s perspective based on hospital stay, cost of sealant application, and cost of complications. One-way sensitivity analysis was used to examine changes in costs as a result of model input changes.Results: In the base case, the cost of the hospital stay for the original surgery, which excludes the cost of complications, dominated costs for both cohorts. On a per patient basis, the use of fibrin glue cost $1666 more than the use of DuraSeal. Sensitivity analysis showed that using lumbar drainage instead of operative repair for a CSF leak reduced cost savings to $680. Holding the incidence of CSF leaks constant for the fibrin glue cohort while increasing the incidence for the DuraSeal cohort by 50% or 300% resulted in cost savings of $1438 and $755, respectively.Conclusions: The results of this study demonstrate a positive, consistent cost-benefit of DuraSeal compared to fibrin glue based on a cohort study of real world patients who underwent posterior fossa neurosurgery.

A Pivotal Randomized Clinical Trial Evaluating the Safety and Effectiveness of a Novel Hydrogel Dural Sealant as an Adjunct to Dural Repair.

A watertight dural repair is critical to minimizing the risk of postoperative complications secondary to cerebrospinal fluid (CSF) leaks. To evaluate the safety and efficacy of a novel hydrogel, Adherus Dural Sealant, when compared with control, DuraSeal Dural Sealant System, as an adjunct to standard methods of dural repair. In this 17-center, prospective, randomized clinical trial designed as a noninferiority, single-blinded study, 124 patients received Adherus Dural Sealant (test sealant) and 126 received DuraSeal (control). The primary composite endpoint was the proportion of patients who were free of any intraoperative CSF leakage during Valsalva maneuver after dural repair, CSF leak/pseudomeningocele, and unplanned retreatment of the surgical site. Each component was then analyzed individually as a secondary endpoint. Patients were followed for 4 mo after surgery. The primary composite endpoint at the 120-d follow-up was achieved in 91.2% of the test sealant group compared with 90.6% of the control, thus showing that the test sealant was statistically significantly noninferior to DuraSeal ( P = .0049). Post hoc analysis of the primary composite endpoint at 14 d demonstrated superiority of the test sealant over the control ( P = .030). Primary endpoint failures in the control group tended to occur early in follow-up period, while a majority of test dural sealant failures were identified through protocol-required radiographic imaging at the 120-d follow-up visit. The test sealant, Adherus Dural Sealant, is a practical, safe, and effective adjunct to achieving a watertight dural closure after primary dural closure in cranial procedures.