1. 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
- Author
-
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, Toxicogenomics, and RS: GROW - School for Oncology and Reproduction
- Subjects
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 - Abstract
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
- Published
- 2012