Efficacy and safety of a collagen matrix for cranial and spinal dural reconstruction using different fixation techniques

2008 ◽  
Vol 109 (2) ◽  
pp. 215-221 ◽  
Author(s):  
Ruediger Stendel ◽  
Marco Danne ◽  
Ingo Fiss ◽  
Ilse Klein ◽  
Andreas Schilling ◽  
...  
Keyword(s):  
Collagen Matrix ◽  
Deep Infection ◽  
Surgical Revision ◽  
Neurosurgical Procedures ◽  
Efficacy And Safety ◽  
Local Skin ◽  
Dural Graft ◽  
Csf Leakage ◽  
Fixation Techniques ◽  
Single Fixation

Object The use of dural grafts is frequently unavoidable when tension-free dural closure cannot be achieved following neurosurgical procedures or trauma. Biodegradable collagen matrices serve as a scaffold for the regrowth of natural tissue and require no suturing. The aim of this study was to investigate the efficacy and safety of dural repair with a collagen matrix using different fixation techniques. Methods A total of 221 patients (98 male and 123 female; mean age 55.6 ± 17.8 years) undergoing cranial (86.4%) or spinal (13.6%) procedures with the use of a collagen matrix dural graft were included in this retrospective study. The indications for use, fixation techniques, and associated complications were recorded. Results There were no complications of the dural graft in spinal use. Five (2.6%) of 191 patients undergoing cranial procedures developed infections, 3 of which (1.6%) were deep infections requiring surgical revision. There was no statistically significant relationship between the operative field status before surgery and the occurrence of a postoperative wound infection (p = 0.684). In the 191 patients undergoing a cranial procedure, cerebrospinal fluid (CSF) collection occurred in 5 patients (2.6%) and a CSF fistula in 5 (2.6%), 3 of whom (1.6%) required surgical revision. No patient who underwent an operation with preexisting CSF leakage had postoperative CSF leakage. Postoperative infection significantly increased the risk for postoperative CSF leakage. The collagen matrix was used without additional fixation in 124 patients (56.1%), with single fixation in 55 (24.9%), and with multiple fixations in 42 (19%). There were no systemic allergic reactions or local skin changes. Follow-up imaging in 112 patients (50.7%) revealed no evidence of any adverse reaction to the collagen graft. Conclusions The collagen matrix is an effective and safe cranial and spinal dural substitute that can be used even in cases of an existing local infection. Postoperative deep infection increases the risk for CSF leakage.

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.

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.

Evaluation of Fibrin Sealants for Central Nervous System Sealing in the Mongrel Dog Durotomy Model

Neurosurgery ◽  
2011 ◽  
Vol 69 (4) ◽  
pp. 921-929 ◽  
Author(s):  
Richard W Hutchinson ◽  
Vince Mendenhall ◽  
Randolph M Abutin ◽  
Tim Muench ◽  
James Hart
Keyword(s):  
Fibrin Sealant ◽  
Tissue Response ◽  
Neurosurgical Procedures ◽  
Fibrin Sealants ◽  
Csf Leakage ◽  
Mongrel Dog ◽  
Tissue Changes ◽  
Foamy Macrophages ◽  
The Brain

Abstract BACKGROUND: Watertight repair of the dura is imperative after neurosurgical procedures involving the brain or spinal cord because inadequately treated leakage of cerebrospinal fluid (CSF) from punctured dura can have serious consequences such as meningitis, arachnoiditis, or epidural abscess. OBJECTIVE: To assess the efficacy of Evicel Fibrin Sealant (Human) to prevent CSF leakage using a 2.0-cm durotomy mongrel dog repair model and to compare the tissue response with Tisseel (a fibrin sealant) and Duraseal (a synthetic polyethylene glycol [PEG] hydrogel sealant). METHODS: The canine durotomy repair model was used. This well-characterized model assesses the ability of sealants to achieve intraoperative watertight seals of the dura mater, as well as long-term safety and efficacy. This study included 27 mongrel dogs and had a 28-day duration. RESULTS: The 3 sealants were 100% effective in preventing CSF leakage intraoperatively at 15 mm Hg. The 2 fibrin sealants were 100% effective in postoperative sealing; the PEG hydrogel was not. Microscopically, the tissue changes induced by Evicel at the durotomy site were similar in nature except for foamy macrophages seen only with the PEG hydrogel. The extent and severity of adhesions at 28 days were less with the fibrin sealants than with the PEG hydrogel. CONCLUSION: Evicel, a fibrin sealant, was safe and effective in achieving and maintaining a watertight seal of the dura. The performance of the fibrin sealants was similar to that of the synthetic PEG hydrogel sealant with the exception of a Duraseal seal, which leaked.

Prospective surveillance of complications in a pediatric neurosurgery unit

2010 ◽  
Vol 5 (6) ◽  
pp. 544-548 ◽  
Author(s):  
James M. Drake ◽  
Jay Riva-Cambrin ◽  
Andrew Jea ◽  
Kurtis Auguste ◽  
Mandeep Tamber ◽  
...  
Keyword(s):  
External Ventricular Drain ◽  
Pediatric Neurosurgery ◽  
Shunt Infection ◽  
Shunt Revision ◽  
Third Ventriculostomy ◽  
Neurosurgical Procedures ◽  
Csf Leakage ◽  
Second Procedure ◽  
Shunt Infections ◽  
Csf Leaks

Object Complications of specific pediatric neurosurgical procedures are well recognized. However, focused surveillance on a specific neurosurgical unit, for all procedures, may lead to better understanding of the most important complications, and allow targeted strategies for quality improvement. Methods The authors prospectively recorded the morbidity and mortality events at a large pediatric neurosurgical unit over a 2-year period. Morbidity was defined as any significant adverse outcome or death (for obstructive shunt failure, within 30 days). Multiple and unrelated complications in the same patient were recorded as separate events. Results There were 1082 surgical procedures performed during the evaluation period. One hundred seventy-seven complications (16.4%) occurred in 147 patients. By procedure, the most common complications occurred in vascular surgery (41.7%) and brain tumor surgery (27.9%). The most common complications were CSF leakage (31 cases), a new neurological deficit (27 cases), early shunt or endoscopic third ventriculostomy obstruction (27 cases), and shunt infection (24 cases). Meningitis occurred in 19 cases: in 58% of shunt infections, 13% of CSF leaks, and 10% of wound infections. Sixty-four percent of adverse events required a second procedure, most commonly an external ventricular drain placement or shunt revision. Conclusions Complications in pediatric neurosurgical procedures are common, result in significant morbidity, and more than half the time require a repeat surgical procedure. Targeted strategies to prevent common complications, such as shunt infections or CSF leaks, might significantly reduce this burden.

A clinicopathological study of collagen sponge as a dural graft in neurosurgery

1995 ◽  
Vol 82 (3) ◽  
pp. 406-412 ◽  
Author(s):  
Pradeep K. Narotam ◽  
James R. van Dellen ◽  
Keshavlal D. Bhoola
Keyword(s):  
Inflammatory Cells ◽  
Wound Infection Rate ◽  
Collagen Sponge ◽  
Neurosurgical Procedures ◽  
Dural Repair ◽  
Content Type ◽  
Initial Surgery ◽  
Dural Graft ◽  
Delayed Hemorrhage ◽  
Fine Print

✓ There is frequently a need for dural grafts to cover defects resulting from retraction, shrinkage, or excision following neurosurgical procedures. Several materials have been evaluated both experimentally and clinically, and then discarded. Collagen, in its various forms, continues to be an area of intense interest. In this study the authors examined the suitability of collagen sponge to effect dural repair. In a 5-year clinical study 102 collagen sponge implants were examined macroscopically and histologically. Graft encapsulation, neomembrane formation, delayed hemorrhage, and foreign body reactions were not found. The porous nature of the collagen sponge encouraged fibroblastic ingrowth and dural repair. Meningocerebral adhesions were present in 11 patients, all of whom had required significant cortical resection or had pia-arachnoid disruption during the initial surgery. Inflammatory cells were seen only in response to infection. Postoperative cerebrospinal fluid leaks developed in only three of 67 patients who underwent an intradural posterior fossa procedure. In a prospective arm of the study involving 459 patients, the wound infection rate using collagen sponge was 6.1%, which compared favorably (p = 0.67) with the 5.7% rate in a similar group of 637 patients in whom collagen sponge had not been used.

scholarly journals Incidence of complications following non-watertight dural reconstruction with a non-suturable, absorbable collagen matrix onlay graft in elective cranial surgery

2020 ◽  
Vol 7 (7) ◽  
pp. 2316
Author(s):  
Asman Ali ◽  
Debadatta Saha
Keyword(s):  
Tumor Resection ◽  
Collagen Matrix ◽  
Alternative Methods ◽  
Csf Leak ◽  
Attractive Alternative ◽  
Consecutive Series ◽  
Cranial Surgery ◽  
Cerebrospinal Fluid Diversion ◽  
Onlay Graft ◽  
Dural Graft

Background: Collagen matrices are effective duraplasty grafts with increasing acceptability. However, little evidences exits for dural reconstruction utilizing monolayer collagen matrix onlay graft in a non-watertight fashion. Purpose of our retrospective analysis was to advance our understanding of the use of semisynthetic collagen as dural substitute in elective cranial surgery.Methods: A consecutive series of sixty patients who underwent elective cranial surgery, where non-watertight dural reconstructions were done with a non-suturable, absorbable collagen matrix onlay graft, has been analysed retrospectively.Results: Overall, the most common indication for duraplasty was tumor resection (93.3%). CSF leak rate was 10.0%. Incidence of aseptic meningitis was 8.3% and all cases has been resolved with steroids alone. Similarly, postoperative surgical site infection rate was 8.3%. Incidence of pseudomeningocele in follow-up was 6.7%. Only in one case (1.7%), permanent CSF (cerebrospinal fluid) diversion was needed due to troublesome CSF leak with associated hydrocephalus.Conclusions: Semisynthetic, monolayer collagen matrix used as an onlay dural graft is a simple, yet an attractive alternative in duraplasty due to their easy handling, lower surgical time, and high biocompatibility, where primary dural closure is undesirable or not feasible. Our study provides greater insight into non-water tight duraplasty procedure.  However, further study is needed to determine the optimal strategy for dural reconstruction. Data from this study may be used to compare alternative methods of dural reconstruction in elective cranial surgery. 

Efficacy and safety of collagen matrix implants in phacotrabeculectomy and comparison with mitomycin C augmented phacotrabeculectomy at 1 year

2013 ◽  
Vol 41 (6) ◽  
pp. 552-560 ◽  
Author(s):  
Arun Narayanaswamy ◽  
Shamira A Perera ◽  
Hla M Htoon ◽  
Sek-Tien Hoh ◽  
Steve K Seah ◽  
...  
Keyword(s):  
Mitomycin C ◽  
Collagen Matrix ◽  
Efficacy And Safety

Neurosurgical Applications of Fibrin Glue: Augmentation of Dural Closure in 134 Patients

Neurosurgery ◽  
1990 ◽  
Vol 26 (2) ◽  
pp. 207-210 ◽  
Author(s):  
Christopher I. Shaffrey ◽  
William D. Spotnitz ◽  
Mark E. Shaffrey ◽  
John A. Jane
Keyword(s):  
Success Rate ◽  
Fibrin Glue ◽  
Disease Transmission ◽  
Neurosurgical Procedures ◽  
Clinical Tool ◽  
Dural Closure ◽  
Single Donor ◽  
Csf Leakage ◽  
Group 2 ◽  
Group 1

Abstract In a wide variety of neurosurgical procedures performed on 134 patients over a 3-year period. fibrin glue has been applied as an adjunct to dural closure. Overall success at preventing cerebrospinal fluid (CSF) leakage was 90% (121 of 134, 90% effective). In patients considered to be at high risk for CSF leakage intraoperatively but without pre-established fistulae (Group 1), the success rate was higher (111 of 119, 93% effective). In patients with pre-established CSF fistulae (Group 2), the success rate was lower (10 of 15, 67% effective). As single donor sources of concentrated fibrinogen are now available with reduced risks of blood-borne disease transmission, fibrin glue may be a valuable clinical tool for the neurosurgeon. (Neurosurgery 26:207-210, 1990)

Occipitocervical fusion using a contoured rod and wire construct in children: a reappraisal of a vintage technique

2013 ◽  
Vol 11 (2) ◽  
pp. 160-169 ◽  
Author(s):  
Paul Klimo ◽  
Nelson Astur ◽  
Kyle Gabrick ◽  
William C. Warner ◽  
Michael S. Muhlbauer
Keyword(s):  
Epithelioid Sarcoma ◽  
Wound Dehiscence ◽  
Patient Characteristics ◽  
Craniocervical Junction ◽  
Atlantoaxial Instability ◽  
Trauma Patients ◽  
Occipitocervical Fusion ◽  
Csf Leakage ◽  
Fixation Techniques

Object Many methods to stabilize and fuse the craniocervical junction have been described. One of the early designs was a contoured (Luque) rod fixated with wires, the so-called Hartshill-Ransford loop. In this study, the authors report their 20-year experience with this surgical technique in children. Methods The authors reviewed the medical records of patients 18 years of age or younger who underwent dorsal occipitocervical fusion procedures between March 1992 and March 2012 at Le Bonheur Children's Hospital using a contoured rod and wire construct. Data on basic patient characteristics, causes of instability, neurological function at presentation and at last follow-up, details of surgery, complications, and radiographic outcome were collected. Results Twenty patients (11 male) were identified, with a mean age of 5.5 years (range 1–18 years) and a median follow-up of 43.5 months. Fourteen patients had atlantooccipital dislocation, 2 patients had atlantoaxial fracture–dissociations, 2 had Down syndrome with occipitocervical and atlantoaxial instability, 1 had an epithelioid sarcoma from the clivus to C-2, and 1 had an anomalous atlas with resultant occipitocervical instability. Surgical stabilization extended from the occiput to C-1 in 3 patients, C-2 in 6, C-3 in 8, and to C-4 in 3. Bone morphogenetic protein was used in 2 patients. Two patients were placed in a halo orthosis; the rest were kept in a hard collar for 6–8 weeks. All patients were neurologically stable after surgery. One patient with a dural tear experienced wound dehiscence with CSF leakage and required reoperation. Eighteen patients went on to achieve fusion within 6 months of surgery; 1 patient was initially lost to follow-up, but recent imaging demonstrated a solid fusion. There were no early hardware or bone failures requiring hardware removal, but radiographs obtained 8 years after surgery showed that 1 patient had an asymptomatic fractured rod. There were no instances of symptomatic junctional degeneration, and no patient was found to have increasing lordosis over the fused segments. Five (31%) of the 16 trauma patients required a shunt for hydrocephalus. Conclusions Despite the proliferation of screw-fixation techniques for craniocervical instability in children, the contoured rod–wire construct remains an effective, less expensive, and technically easier alternative that has been in use for almost 30 years. It confers immediate stability, and therefore most patients will not need to be placed in a halo device postoperatively. A secondary observation in our series was the high (30%) rate of hydrocephalus requiring a shunt in patients with traumatic instability.

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