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This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. This article has been cited by other articles in PMC.
Abstract Background: Post-operative cerebrospinal fluid CSF leak in posterior fossa surgery remains a significant source of morbidity.
A comparison with one of the most commonly used dural sealing devices, DuraSeal, has been made. Methods: A retrospective, single-center study was conducted on patients who underwent elective posterior fossa surgery. The presence of pre- and post-operative risk factors was associated with an increased incidence of CSF leak in both groups. The incidence of CSF leak in patients who underwent posterior fossa surgery by craniectomy was statistically lower in TPD group compared to DuraSeal group 3.
The CSF leak rate in TPD group was found to be lower or within the range of the more advanced alternative dural closure strategies, including polyethylene glycol PEG -based sealant. Current treatments aim to promote wound healing by reducing CSF pressure CSF lumbar drainage or repeated spinal taps and to prevent infections by administering intravenous antibiotics to the patient.
Failure of these treatments potentially requires further surgical intervention. In spite of these treatments, infections, meningitis, encephalitis, and pseudomeningocele formation may complicate the post-operative course and result in permanent damage or delay the beginning of adjuvant therapy in oncologic cases. A number of studies have reported a reduction in the incidence of CSF leakage, but only one study considered the incidence of CSF leaks following posterior fossa surgery.
In this retrospective, non-randomized, single-center study, the authors compared the safety and effectiveness of this novel sealant film TPD with DuraSeal, a synthetic liquid formulation, in reducing the incidence of both incisional CSF leak and pseudomeningocele following posterior fossa surgery.
Informed consent was obtained from all patients. Pre-operative admission criteria included adult patients undergoing clean elective surgical procedures. Previous radiotherapy RT , previous surgery, and chronic corticosteroid therapy were not considered the exclusion criteria. Of these patients females and 53 males; mean age 45 years, range years , were treated with TPD and 46 with DuraSeal. Table 1 Pre-, intra-, and post-operative risk factors in the patients submitted to surgical procedures for infratentorial pathologies Open in a separate window All patients underwent daily post-operative wound examination in order to assess the occurrence of subgaleal CSF collection, incisional CSF leak, any inflammatory reaction, or wound infection.
To monitor post-operative complications, a brain CT or MR scan was performed within 48 h in all patients who underwent lesion resection and occipito-axial decompression for Chiari malformation. Patients with neurovascular conflicts who underwent microvascular decompression were only scanned if they displayed clinical symptoms. The wound was then examined at 2 weeks and 6 months after surgery. Demographic data and operative and outcome data were collected and analyzed.
The etiology of these complications is leakage of CSF from the subarachnoid space into the extradural compartment. When the skin incision has adequately healed, a pseudomeningocele may develop; otherwise, an incisional CSF leak may occur. Both situations should be considered as a failure of the dural sealant to prevent CSF from leaking to the extradural compartment.
Poly lactide-co-glycolide is a resorbable membrane that provides reliable strength for temporary wound support. According to data provided by the manufacturer Tissuemed Ltd, Leeds, UK see the product instructions for use , the material achieves its adhesive properties by virtue of the initial tack provided by poly acrylic acid and poly vinyl pyrrolidone functional groups and longer term adhesion via nucleophilic substitution reaction between N-hydroxysuccinimide NHS and amines.
TPD remains in position while it slowly degrades until substantially reabsorbed facilitating tissue in-growth and wound healing.
Postoperative Cervical Cord Compression Induced by Hydrogel Dural Sealant (DuraSeal®)
Corresponding author. This article has been cited by other articles in PMC. Abstract Cerebrospinal fluid CSF leakage is a potential complication of cranial and spinal surgery. Postoperative CSF leakage can induce delayed healing, wound infection and meningitis. Postoperative CSF leakage can induce delayed healing, wound infection and meningitis 5 , 7.
UPDATE 1-Covidien DuraSeal product gets FDA approval
N Duraseal sealant for use in spinal surgeries as long as the company gathers more data. The panel of outside experts voted in favor of the product, which is already FDA-approved for use in cranial surgeries. Covidien is seeking FDA approval to more widely market Duraseal, a synthetic polymer that is sprayed onto the surgical site to provide a watertight seal, for use in addition to traditional sutures. Properly closing incisions in brain and spinal surgeries prevents cerebral spinal fluid from leaking, which can cause complications such as infection. But surgical sutures alone can leave small gaps.