Med. J. Cairo Univ., Vol. 80, No. 1, March: 181-184, 2012
www.medicaljournalofcairouniversity.com
DuraSeal Xact Adhesion Barrier and Sealant System: An Advanced
Hydrogel Technology for Watertight Dural Repair in Spinal Cases
SALEM FAISAL, M.D.; Ph.D.
The Department of Neurosurgery, Faculty of Medicine, Suez Canal University, Ismailia
Abstract
Introduction: Cerebrospinal fluid leakage is a major
problem in neurosurgical operations. A large variety of biologic
and artificial materials have been suggested as sealant for
achieving a watertight dural closure. We prospectively evaluated the safety and efficacy of a duraSeal Xact adhesion
barrier and sealant system in patients with predicted CSF
leaks after sutured spinal dural closure.
Material and Methods: This study is a prospective clinical
trial in 25 patients who need spinal dural augmentations.
DuraSeal Xact system was used in 19 patients underwent
intentional spinal durotomy and 6 patients who had unintended
incidental durotomy. Patients were followed up for 3 months
postoperatively with clinical examinations and diagnostic
imaging.
performed for the excision of intradural spinal
tumors, and 17.6% for surgical management of
tethered cord syndrome [2,3] . Postoperative CSF
leakage poses a risk of significant morbidity with
the potential for meningitis, pseudomeningoceles,
impaired wound healing [4] .
A wide variety of methods have been used for
dural repair including interrupted sutures (possibly
using duraplasty to cover significant dural gaps),
adhesives, hemostatic agents and other preparations.
Key Words: Dura mater – Cerebrospinal fluid leak – DuraSeal
Xact system.
Dural sealant system (polyethylene glycolbased synthetic hydrogel) is indicated and approved
for use as an adjunct to sutured dural repair during
cranial surgery to provide watertight closure. The
DuraSeal Xact system used for spinal surgery is a
modification of the latter in which the structure of
the gel has been changed to avoid excessive osmotic
swelling of the gel in the spinal canal to prevent
compression of its content. Recently, the DuraSeal
Xact system is intended for use as an adjunct to
sutured dural repair during spinal surgery to obtain
watertight closure.
Introduction
Material and Methods
CEREBROSPINAL fluids (CSF) leakage has
been a troublesome problem in cerebral or spinal
operative procedures for many years. Leakage may
occur at the dural suture line postoperatively or is
caused by inadvertent dural tears during extradural
spinal approaches for disc surgery or decompressive
laminectomy [1] .
Our study included 25 patients who underwent
spinal operative procedures between 2006 and
2009 in neurosurgery department in Suez Canal
university hospital. The study included 19 cases
scheduled for elective spinal procedures involving
a dural incision while in the remaining 6 cases the
dural tear occurred accidentally. Patients with dural
gap >2mm remaining after primary dural closure
were excluded. The most common indications for
surgery included resection of spinal tumors (32%),
myelomeningiocele (20%), Chiari malformation
(16%), disc surgery (16%), Decomporessive laminectomies (8%), and syringomyelia (8%).
Results: DuraSeal Xact system was effective in preventing
CSF leaks in all patients. We have observed only 2 complications with uncertain relationship with the used system.
Conclusion: DuraSeal Xact system meets the clinical
challenge to reliably seal the dura to prevent CSF leak. It may
also facilitate subsequent reoperations by acting as a mechanical barrier to adhesion formation.
The incidence of CSF leaks after spinal procedures where intradural exploration is undertaken
has been reported to be as high as 10.4% in surgery
Correspondence to: Dr. Salem Faisal,
Email: [email protected]
181
182
All patients were treated with duraSeal after
sutured dural repair. The sealant is provided as a
single prepackaged unit with two syringes containing a polyethylene glycol (PEG) ester solution and
trilysine amine solution, a vial containing endmodified PEG powder and a spraying device. To
prepare the sealant, the diluent is injected into the
powder vial, and the dissolved PEG/dye and amine
solution polymerize to form a biocompatible absorbable hydrogel within 2 seconds without detectable heat evolution and without external energy
sources. These solutions are sprayed onto the dura
mater and result in a conformal coating that adheres
to the tissue surfaces. The cross linked solid hydrogel is more than 90% water at application, due
to this high water content the hydrogel has physical
properties similar to tissue and can be used for up
to one hour following reconstitution. The blue dye
in the dilution helps to determine sealant coverage
and thickness. The hydrogel implant is absorbed
in approximately 4 to 8 weeks with excretion from
the body through the kidneys.
After the hydrogel sealant had been applied,
patients were assessed for intraoperative CSF
leakage from the repaired dura during valsava
maneuvers. If CSF leakage persisted, a second
coating of hydrogel sealant was applied and tested
again. Patients were examined postoperatively at
discharge, at one month and at 3 months.
DuraSeal Xact Adhesion Barrier and Sealant System
All patients were followed at discharge, 30
days post-procedure, 90 days post-procedure for
any evidences of CSF leakage as open leakage, or
pseudomeningocele, surgical site infection, wound
healing assessment, neurological status and adverse
events.
Results
Our study included 13 males and 12 females.
Mean age was 49.6 ± 14.1. Spinal procedures were
performed in 25 patients, with excision of intradural
spinal tumors in 8 cases (32%), surgical management of myelomeningocele in 5 cases (20%), surgical correction of Chiari malformation in 4 cases
(16%), and 3 cases (12%) underwent lumber disc
surgery, 3 cases (12%) had decompressive laminectomies, while the remaining 2 cases (8%) underwent surgery for syringiomyelia (Tables 1,2).
A single PEG hydrogel sealant application was
effective in obtaining a watertight closure in 22
patients (88%). Persistent leakage after initial
application was present in 3 patients (12%). One
leak was spontaneous and two leaks were induced
by the valsalva maneuver. All 3 patients were
treated successfully with a second hydrogel application and did not have a CSF leak after a subsequent valsalva maneuver (Table 3).
No local or systemic reaction to the sealant
system was noted. No adverse events were detected
in 24 cases (96%) while one patient (4%) had deep
infection of the surgical site. In the early postoperative period, most patients had some expected
local swelling at the incision site. At one month
postoperatively, the swelling had resolved in 20
patients (80%) and at 3 months, the wounds of all
patients were healed (Table 4).
The effectiveness of duraSeal Xact system in
preventing CSF leak was assessed intraoperatively.
25 cases achieved 100% success at time of surgery.
There were no signs of CSF leaks in 25 cases
(100%) from discharge to one month postoperatively. A pseudomeningiocele was detected in one
case (4%), 35 days postoperatively and treated
successfully by lumber drain (Table 4).
Table (1): Patient's demographics.
Fig. (1,2): Application of hydrogel sealant after surgical
excision of intradural spinal tumors.
No.
%
≤ 18 years
Between 18-65 years
≥65 years
0
20
5
0
80
20
Age
Mean ± standard deviation
49.7± 14.1
Gender
Male
Female
13
12
52
48
Salem Faisal
183
Table (2): Types of spinal procedures and numbers in patients
treated with duraseal sealant system.
Procedure
No.
%
Intentional durotomy
Spinal tumors
Myelomeningocele
Chiari malformation
Syringomyelia
19
8
5
4
2
76
32
20
16
8
Unintended durotomy
Disc surgery
Decompressive laminectomy
6
3
3
24
12
12
Table (3): Intraoperative assessment of watertight closure.
First application
No leak
Leak
Spontaneous
Leak upon valsalva
Second application
No leak
Leak
No.
%
22
3
1
2
88
12
4
8
3
0
100
0
Table (4): Clinical outcomes and morbidity.
30 days
postoperative
N. (%)
Parameter
CSF leak:
Open leakage
pseudomeningocele
Surgical site infection
Postoperative fever
0
0
1
1
(0.0)
(0.0)
(4)
(4)
90 days
postoperative
N. (%)
0
1
0
0
(0.0)
(4)
(0.0)
(0.0)
Discussion
After spinal operative procedures, it is imperative to provide a complete and watertight dural
closure to avoid the complications. Common effects
of CSF Ieaks include vomiting, headaches, nausea,
photophobia and tinnitus [5-7] . More serious consequences of non-watertight primary closure may
include formation of fistulas leading to possible
meningitis, arachnoiditis or epidural abscess [8] .
A fluid collection may also impede wound healing
and lead to infection of the wound. Pseudomeningoceles may result in nerve deficits and possible
nerve root entrapment [9,10] . Persistent CSF leak
has also been associated with the development of
cerebellar hemorrhage, and intracranial subdural
hematoma, presumably due to altered CSF dynamics resulting in caudally-directed movement of the
spinal cord and brain, which in turn stretches fragile
bridging veins with eventual rupture in the subdural
space [11,12] .
In current practice, watertight dural closure
with sutures alone is not pssible in many cases.
Any adjuvant method that can provide a watertight
dural closure would be advantageous and desired.
Various substances such as hemostatic agents (e.g.,
Gelfoam), fibrin glue sealant (e.g., Tisseel), bovine
adhesive glue (e.g., Bio Glue) and duraplasty
materials (e.g., Duragon) have been used for a
watertight dural closure but none are currently
approaved by the FDA for this indication.
In a review of literature, the rate of postoperative
CSF leak following surgery where intradural exploration is undertaken has been reported to be as
high as 10.4% in surgery performed for the excision
of intradural tumors, 17.6% for surgical management of tethered cord syndrome and approximately
13% for surgical correction of chiari malformation
[2,3,13] .
A prospective review of 76 patients undergoing
lumber surgery reported 16% of patients experienced a postoperative CSF leak [14] . Even with
meticulous attempts at a watertight seal, utilizing
sutures augmented with fibrin glue, postoperative
CSF leaks still occur in 5-10% of cases [15] . In a
retrospective review performed by hodges and
coleagues, twenty incidental durotomies following
spinal procedures were repaired intraoperatively
with dural stitches and fibrin glue. Of the twenty
patients, 25% had symptoms related to the dural
tear and one patient (5%) required revision surgery
due to stitch loosening [16] . The duraSeal Xact
system used in this study seems ideally to its task
as it is nonbiological and therefore does not transmit
viruses. The sealant is biocompatible (and therefore
does not interfere with healing), absorbable, flexible, and strongly adherent to tissue. In our study,
the PEG hydrogel sealant was 100% effective in
sealing intraoperative CSF leaks. One patient (4%)
experienced deep surgical site infection and another
patient (4%) had postoperative pseudomeningiocele. These results compare favorably with the 4
to 30% reported incidence of postoperative CSF
leaks in other large surgical series [3,17,18] .
In the majority of cases (88%), an intraoperative
watertight closure was obtained following one
application of the duraseal spine sealant, thus
eliminating the need for additional application/valsalva maneuvres to confirm watertight dural
closure. However, in only 3 cases (12%) a second
kit was assembled and the sealant was applied with
no additional issues. Most notably, in all subjects
treated with the spinal sealant (100%) the author
was able to obtain a watertight dural closure after
applying the spinal sealant only. That is, in no
184
DuraSeal Xact Adhesion Barrier and Sealant System
cases was there a need to apply any further adjunctive therapy (e.g,additional sutures, fibrin glue) to
seal the dura, thus eliminating the additional time
and cost of applying additional dural sealing products and associated lengthened surgery time.
Conclusion:
The dura seal spine sealant is a synthetic polymer that demonstrate a significant clinical benefit
by eliminating the risks from material of animal
or human origin, reducing surgical and closure
time and most significantly, providing a watertight
dural seal.
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