scholarly journals Modified Shoelace Dural Closure With Collagen Matrix in Extended Transsphenoidal Surgery

2021 ◽  
Author(s):  
Yuichi Nagata ◽  
Kazuhito Takeuchi ◽  
Hiroo Sasaki ◽  
Akihiro Mizuno ◽  
Hideyuki Harada ◽  
...  
Keyword(s):  
Transsphenoidal Surgery ◽  
Collagen Matrix ◽  
Closure Technique ◽  
Dural Closure ◽  
Reconstruction Methods ◽  
Csf Leakage ◽  
Effective Option ◽  
Tuberculum Sellae ◽  
Surgical Field ◽  
Sellar Reconstruction

Abstract 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

scholarly journals A Comparative Study between Autologous Dural Closure versus Collagen Matrix (DuraGen) Closure in Decompressive Craniectomy for Trauma

2020 ◽  
Vol 17 (01) ◽  
pp. 46-49
Author(s):  
Rajesh Kumar Barooah ◽  
Basanta Kumar Baishya ◽  
Hriday Haloi ◽  
Mrinal Bhuyan ◽  
Asman Ali ◽  
...  
Keyword(s):  
Wound Infection ◽  
Decompressive Craniectomy ◽  
Operating Time ◽  
Collagen Matrix ◽  
Dural Defect ◽  
Temporalis Fascia ◽  
Dural Closure ◽  
Fascia Graft ◽  
Dural Graft ◽  
Csf Leakage

Abstract Introduction Neurosurgeons often deal with the problem of a complete and watertight dural closure after cerebral operative procedures. In decompressive craniectomy done for trauma, autologous grafts such as galea, temporalis fascia can be time consuming. Hence this study was undertaken to look into the outcome using collagen matrix graft for dural closure. Aims and Objectives To study the difference between autologous dural graft closure and collagen matrix graft with respect to the time taken for closure, cerebrospinal fluid (CSF) leakage, and wound infection. Methods This prospective study includes 30 patients who underwent decompressive craniectomy for trauma. Duraplasty with temporalis fascia graft and nonautologous collagen matrix dural patch was done by randomization. Specific time points during craniectomy and cranioplasty was calculated. Total time for the procedures and the time for dural repair and separation was calculated. Results The use of collagen matrix in decompressive craniectomy resulted in decrease in mean operative time during the first surgery by average 45 minutes (p< 0.5) as compared to the use of autologous graft. There is reduction in the operating time during second surgery (cranioplasty) by 35 minutes (p< 0.5). The patients using collagen matrix graft did not record any CSF leakage or wound infection. Excellent uptake of the collagen by the duramater was seen. Conclusion The use of collagen to cover the dural defect for decompressive craniectomy for trauma results in significant reduction in the operating time during the first surgery and also in cranioplasty. There is reduction in CSF leakage and hence duration of hospital stay and cost.

Novel Dural Closure Technique Using Polyglactin Acid Sheet Prevents Cerebrospinal Fluid Leakage after Spinal Surgery

2005 ◽  
Vol 57 (suppl_4) ◽  
pp. ONS-290-ONS-294 ◽  
Author(s):  
Taku Sugawara ◽  
Yasunobu Itoh ◽  
Yoshitaka Hirano ◽  
Naoki Higashiyama ◽  
Yoichi Shimada ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Cerebrospinal Fluid ◽  
Magnetic Resonance ◽  
Fibrin Glue ◽  
Spinal Surgery ◽  
Cerebrospinal Fluid Leakage ◽  
Resonance Imaging ◽  
Closure Technique ◽  
Dural Closure ◽  
Csf Leakage

Abstract OBJECTIVE: Extradural or subcutaneous cerebrospinal fluid (CSF) leakage is a common complication after spinal surgery and is associated with the risks of poor wound healing, meningitis, and pseudomeningocele. Numerous methods to prevent postoperative CSF leakage are available, but pressure-tight dural closure remains difficult, especially with synthetic surgical membranes. The efficacy of a novel dural closure technique was assessed by detecting extradural or subcutaneous CSF leakage on magnetic resonance imaging. METHODS: The novel dural closure technique using absorbable polyglactin acid sheet and fibrin glue and the conventional procedure using only fibrin glue were evaluated retrospectively by identifying extradural or subcutaneous CSF leakage on magnetic resonance imaging scans in the acute (2–7 d) and chronic (3–6 mo) postoperative stages after spinal intradural surgery in 53 patients. RESULTS: The incidence of extradural and subcutaneous CSF leakage was significantly lower (P &lt; 0.05) in the acute (20%) and chronic (0%) stages using polyglactin acid sheet and fibrin glue in 15 patients compared with that in the acute (81%) and chronic (24%) stages using only fibrin glue in 38 patients. One patient in the fibrin glue-only group required repair surgery for cutaneous CSF leakage. CONCLUSION: The combination of polyglactin acid sheet and fibrin glue can achieve water-tight closure after spinal intradural surgery and can minimize the risk of intractable postoperative CSF leakage. This simple, economical technique is recommended for dural closure after spinal intradural surgery.

Sellar reconstruction with resorbable vicryl patches, gelatin foam, and fibrin glue in transsphenoidal surgery: a 10-year experience with 376 patients

2000 ◽  
Vol 93 (5) ◽  
pp. 762-765 ◽  
Author(s):  
Rolf W. Seiler ◽  
Luigi Mariani
Keyword(s):  
Fibrin Glue ◽  
Transsphenoidal Surgery ◽  
Operating Time ◽  
Sella Turcica ◽  
Morbidity Rate ◽  
Surgical Incision ◽  
Content Type ◽  
Csf Leakage ◽  
Sellar Reconstruction ◽  
Fine Print

Object. Closure of the sella turcica after transsphenoidal surgery is mainly accomplished with autologous muscle fascia and fat or muscle; this requires a second surgical incision. The authors review the results of using resorbable vicryl patches, gelatin foam, and fibrin glue for sellar reconstruction.Methods. A review was conducted of 376 consecutive patients who underwent surgery for pituitary adenomas, cysts, or subdiaphragmatic craniopharyngiomas in the sella turcica that the senior author (R.W.S.) had performed or directly supervised over the last 10 years. The sellar reconstruction was performed with a commercially available, synthetic absorbable patch composed of polyglactin 910/poly-p-dioxanone, gelatin foam, and fibrin glue. The patch is essentially resorbed in 2 to 3 months and replaced by fibrous collagen tissue. There were 117 small, 112 medium-sized, and 147 large lesions. The overall nonendocrine postoperative morbidity rate was 2.8%, and included visual deterioration, meningitis, secondary epistaxis, nasal septum complication, and cerebrospinal fluid (CSF) leakage. Two patients with macroadenomas needed reoperation for persistent CSF leakage, which comprised 0.5% of the whole series or 0.8% of the 259 patients with medium-sized or large lesions. There was no mortality and no morbidity related to the implanted material, and in particular no delayed empty sella syndrome.Conclusions. Closure of the sella turcica with a synthetic absorbable vicryl patch, gelatin foam, and fibrin glue after transsphenoidal surgery is safe and very effective in preventing postoperative CSF fistulas. The use of this technique obviates the need for a second surgical incision and shortens the operating time. Because of the progressive resorption of the substitute material, the interpretation of postoperative magnetic resonance studies was not significantly hindered.

scholarly journals Simple closure following transsphenoidal surgery

2006 ◽  
Vol 20 (3) ◽  
pp. 1-3 ◽  
Author(s):  
William T. Couldwell ◽  
Peter Kan ◽  
Martin H. Weiss
Keyword(s):  
Cerebrospinal Fluid ◽  
Transsphenoidal Surgery ◽  
Operative Time ◽  
Sella Turcica ◽  
Csf Leak ◽  
Simple Closure ◽  
Autologous Fat ◽  
Csf Leakage ◽  
Muscle Fascia ◽  
Sellar Reconstruction

✓ The most common nonendocrine complication after transsphenoidal surgery is cerebrospinal fluid (CSF) leak. Many neurosurgeons have advocated the routine reconstruction of the floor of the sella turcica using autologous fat, muscle, fascia, and either cartilage or bone after transsphenoidal surgery to prevent postoperative CSF fistulas. However, the use of autologous grafting requires a second incision, prolongs operative time, and adds to the patient's postoperative discomfort. In addition, the presence of sellar packing may interfere with the interpretation of postoperative images. To avoid these disadvantages, the authors suggest that routine sellar reconstruction or closure after transsphenoidal surgery is unnecessary unless an intraoperative CSF leak is encountered. The incidence of postoperative CSF leakage in the patients reported on in this series is no higher than that reported by others, and no other complications such as pneu-matocele have been encountered in approximately 2700 patients in whom no intraoperative CSF leak was encountered. The authors conclude that routine closure of the floor of the sella turcica or sphenoid is unnecessary in the absence of intraoperative CSF leak.

scholarly journals Outcomes of endoscopic transsphenoidal surgery for Cushing's disease

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zarina Brady ◽  
Aoife Garrahy ◽  
Claire Carthy ◽  
Michael W. O’Reilly ◽  
Christopher J. Thompson ◽  
...  
Keyword(s):  
Diabetes Insipidus ◽  
Cushing’S Disease ◽  
Transsphenoidal Surgery ◽  
Remission Rate ◽  
Cushing's Disease ◽  
Endoscopic Transsphenoidal Surgery ◽  
Endocrine Society ◽  
Csf Leakage ◽  
Remission Rates

Abstract Background Transsphenoidal surgery (TSS) to resect an adrenocorticotropic hormone (ACTH)-secreting pituitary adenoma is the first-line treatment for Cushing’s disease (CD), with increasing usage of endoscopic transsphenoidal (ETSS) technique. The aim of this study was to assess remission rates and postoperative complications following ETSS for CD. Methods A retrospective analysis of a prospective single-surgeon database of consecutive patients with CD who underwent ETSS between January 2012–February 2020. Post-operative remission was defined, according to Endocrine Society Guidelines, as a morning serum cortisol < 138 nmol/L within 7 days of surgery, with improvement in clinical features of hypercortisolism. A strict cut-off of < 50 nmol/L at day 3 post-op was also applied, to allow early identification of remission. Results A single surgeon (MJ) performed 43 ETSS in 39 patients. Pre-operative MRI localised an adenoma in 22 (56%) patients; 18 microadenoma and 4 macroadenoma (2 with cavernous sinus invasion). IPSS was carried out in 33 (85%) patients. The remission rates for initial surgery were 87% using standard criteria, 58% using the strict criteria (day 3 cortisol < 50 nmol/L). Three patients had an early repeat ETSS for persistent disease (day 3 cortisol 306-555 nmol/L). When the outcome of repeat early ETSS was included, the remission rate was 92% (36/39) overall. Remission rate was 94% (33/35) when patients with macroadenomas were excluded. There were no cases of CSF leakage, meningitis, vascular injury or visual deterioration. Transient and permanent diabetes insipidus occurred in 33 and 23% following first ETSS, respectively. There was one case of recurrence of CD during the follow-up period of 24 (4–79) months. Conclusion Endoscopic transsphenoidal surgery produces satisfactory remission rates for the primary treatment of CD, with higher remission rates for microadenomas. A longer follow-up period is required to assess recurrence rates. Patients should be counselled regarding risk of postoperative diabetes insipidus.

scholarly journals Single-arm, open-label, multicentre first in human study to evaluate the safety and performance of dural sealant patch in reducing CSF leakage following elective cranial surgery: the ENCASE trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e049098
Author(s):  
Tristan Van Doormaal ◽  
Menno R Germans ◽  
Mariska Sie ◽  
Bart Brouwers ◽  
Andrew Carlson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Primary Endpoint ◽  
User Satisfaction ◽  
Neurosurgical Procedures ◽  
Open Label ◽  
Cranial Surgery ◽  
Dural Closure ◽  
Handling Characteristics ◽  
Csf Leakage ◽  
And Performance

ObjectiveThe dural sealant patch (DSP) is designed for watertight dural closure after cranial surgery. The goal of this study is to assess, for the first time, safety and performance of the DSP as a means of reducing cerebrospinal fluid (CSF) leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.DesignFirst in human, open-label, single-arm, multicentre study with 360-day (12 months) follow-up.SettingThree large tertiary reference neurosurgical centres, two in the Netherlands and one in Switzerland.ParticipantsForty patients undergoing elective cranial neurosurgical procedures, stratified into 34 supratentorial and six infratentorial trepanations.InterventionEach patient received one DSP after cranial surgery and closure of the dura mater with sutures.Outcome measuresPrimary composite endpoint was occurrence of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O positive end-expiratory pressure or postoperative wound infection. Overall success was defined as achieving the primary endpoint in no more than two patients. Secondary endpoints were device-related serious adverse events or adverse events (AEs), pseudomeningocele and thickness of dura+DSP. Additional endpoints were reoperation in 30 days and user satisfaction.ResultsNo patients met the primary endpoint. No device-related (serious) AEs were observed. There were two incidences of self-limiting pseudomeningocele as confirmed on MRI. Thickness of dura and DSP were (mean±SD) 3.5 mm±2.0 at day 7 and 2.1 mm±1.2 at day 90. No patients were reoperated within 30 days. Users reported a satisfactory design and intuitive application.ConclusionsDSP, later officially named Liqoseal, is a safe and potentially efficacious device for reducing CSF leakage after intracranial surgery, with favourable clinical handling characteristics. A randomised controlled trial is needed to assess Liqoseal efficacy against the best current practice for reducing postoperative CSF leakage.Trial registration numberNCT03566602.

The safety and effectiveness of a dural sealant system for use with nonautologous duraplasty materials

2010 ◽  
Vol 112 (2) ◽  
pp. 428-433 ◽  
Author(s):  
Jason S. Weinstein ◽  
Kenneth C. Liu ◽  
Johnny B. Delashaw ◽  
Kim J. Burchiel ◽  
Harry R. van Loveren ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Adverse Events ◽  
Surgical Site Infections ◽  
Study Group ◽  
Pivotal Trial ◽  
Safety And Efficacy ◽  
Dural Closure ◽  
System A ◽  
Csf Leakage ◽  
Csf Leaks

Object The DuraSeal dural sealant system, a polyethylene glycol hydrogel, has been shown to be safe and effective when used with commercial and autologous duraplasty materials. The authors report on the safety and effectiveness of this sealant when used in conjunction with nonautologous duraplasty materials. Methods In this retrospective, nonrandomized, multicenter study, the safety and efficacy of a dural sealant system was assessed in conjunction with primarily collagen-based nonautologous duraplasty materials in a sample of 66 patients undergoing elective cranial procedures at 3 institutions. This cohort was compared with 50 well-matched patients from the DuraSeal Pivotal Trial who were treated with this sealant system and autologous duraplasty material. Results The key end points of the study were the incidences of CSF leaks, surgical site infections, and meningitis 90 days after surgery. The incidence of postoperative CSF leakage was 7.6% in the study group (retrospective population) and 6.0% in the Pivotal Trial population. The incidence of meningitis was 0% and 4.0% in the retrospective and Pivotal Trial groups, respectively. There were no serious device-related adverse events or unanticipated adverse device effects noted for either population. Conclusions This study demonstrates that the DuraSeal sealant system is safe and effective when used for watertight dural closure in conjunction with nonautologous duraplasty materials.

scholarly journals Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing Cerebrospinal Fluid Leakage Following Elective Cranial Surgery: The ENCASE Trial Study Protocol

Neurosurgery ◽  
2019 ◽  
Author(s):  
Tristan P C van Doormaal ◽  
Menno R Germans ◽  
Mariska Sie ◽  
Bart Brouwers ◽  
Jorn Fierstra ◽  
...  
Keyword(s):  
Cerebrospinal Fluid ◽  
Primary Endpoint ◽  
Multicenter Study ◽  
Controlled Trial ◽  
Cerebrospinal Fluid Leakage ◽  
Open Label ◽  
Cranial Surgery ◽  
Dural Closure ◽  
Csf Leakage ◽  
And Performance

Abstract BACKGROUND Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4% to 32% of surgical cases, with a higher incidence in complicated skull base surgery, intradural spine surgery, and the surgery of the posterior fossa. Our group developed a Dural Sealant Patch (DSP) for watertight dural closure after cranial surgery. OBJECTIVE To clinically study for the first time the safety and performance of the DSP as a means of reducing CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure. METHODS We will conduct an open-label, single-arm, multicenter study with a 360 d (12 mo) follow-up. A total of 40 patients will be enrolled at 3 sites. The primary endpoint is a combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection. The secondary endpoints are pseudomeningocele and thickness of dura + DSP. EXPECTED OUTCOMES Not more than 3 patients will meet the primary endpoint suggesting safety and efficacy. DISCUSSION As a next step, a randomized controlled trial against the best current practice will follow to evaluate if DSP reduces CSF leakage while its safety is noninferior.

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