A Multicenter, Single-Blind, Prospective Randomized Trial to Evaluate the Safety of a Polyethylene Glycol Hydrogel (Duraseal Dural Sealant System) as a Dural Sealant in Cranial Surgery
| Autor: | Mark E. Shaffrey, Joshua W. Osbun, J. Paul Muizelaar, Jeremy D.W. Greenlee, Mitesh V. Shah, Patrick J. Connolly, Martin E. Weinand, John G. Golfinos, James E. Wilberger, Richard G. Ellenbogen, John M. Tew, Stephen J. Haines, Johnny B. Delashaw, Randall M. Chesnut, Anil Nanda, Harry R. van Loveren, Jonathan White, G. Rees Cosgrove, Lawrence S. Chin, Jack Jallo |
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| Přispěvatelé: | Toxicogenomics, RS: GROW - School for Oncology and Reproduction |
| Jazyk: | angličtina |
| Rok vydání: | 2012 |
| Předmět: |
Male
Leak medicine.medical_specialty Cerebrospinal Fluid Rhinorrhea PEG hydrogel medicine.medical_treatment DuraSeal Polyethylene Glycol Hydrogel Fibrin Neurosurgical Procedures Polyethylene Glycols Cranial surgery Cerebrospinal fluid Postoperative Complications otorhinolaryngologic diseases Valsalva maneuver medicine Humans Surgical Wound Infection Single-Blind Method CSF leak Brain Diseases biology Cerebrospinal Fluid Leak business.industry Sealant Suture Techniques technology industry and agriculture Middle Aged medicine.disease Surgery Pseudomeningocele Drug Combinations Dural sealant Treatment Outcome Anesthesia biology.protein Female Neurology (clinical) Dura Mater business Meningitis Oligopeptides |
| Zdroj: | World Neurosurgery, 78(5), 498-504. Elsevier Science |
| ISSN: | 1878-8750 |
| Popis: | Incisional cerebrospinal fluid (CSF) leakage after cranial surgery is a significant cause of morbidity due to poor wound healing and infection, meningitis, and pseudomeningocele formation. Many common dural closure techniques, such as sutures, autologous grafts, gelatin or collagen sponges, and fibrin glues, are used to achieve watertight closure, although none are US Food and Drug Administration approved for this use. DuraSeal Dural Sealant System is a polyethylene glycol (PEG) hydrogel approved by the U.S. Food and Drug Administration for obtaining watertight dural closure when applied after standard dural suturing. This multicenter, prospective randomized study further evaluated the safety of a PEG hydrogel compared with common dural sealing techniques.A total of 237 patients undergoing elective cranial surgery at 17 institutions were randomized to dural closure augmented with the PEG hydrogel or a control "standard of care" dural sealing technique after Valsalva maneuver demonstrated an intraoperative nonwatertight dural closure. Data were collected on complications resulting in unplanned postoperative interventions or reoperations, surgical site infections, CSF leaks, and other neurological complications within 30 days. Surgeons also provided data on the ease of use of the dural sealing techniques, as well as preparation and application times.The incidences of neurosurgical complications, surgical site infections, and CSF leaks were similar between treatment and control groups, with no statistically significant difference between the measures. In the PEG hydrogel group (n = 120), the incidence of neurosurgical complications was 5.8% (n = 7), the incidence of surgical site infections was 1.7% (n = 2), and the incidence of CSF leak was 0.8% (n = 1). In the control group (n = 117), the incidence of neurosurgical complications was 7.7% (n = 9), the incidence of surgical site infection was 2.6% (n = 3), and the incidence of CSF leak was 1.7% (n = 2). Sealant preparation time was less than 5 minutes in 96.6% of the PEG hydrogel group compared with 66.4% of controls (P |
| Databáze: | OpenAIRE |
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