title: Spinal sealant system provides better intraoperative watertight closure than standard of care during spinal surgery: a prospective, multicenter, randomized controlled study.
abstract: METHODS
  Prospective, 3:1 randomized, single-blind, multicenter investigational study.
  
  
  OBJECTIVE
  To assess the safety and efficacy of a low-swell spinal sealant when used as an adjunct to sutured dural repair compared with standard of care methods to obtain watertight dural closure in subjects undergoing spinal surgery.
  
  
  BACKGROUND
  Watertight dural closure is paramount in spinal surgery to avoid complications of cerebrospinal fluid leak. Prior reports have proven the efficacy of a synthetic, absorbable polyethylene glycol (PEG) hydrogel sealant in spinal surgery compared with standard of care. Given the potential concerns of swelling in spinal applications, the hydrogel was modified to a low-swell formulation.
  
  
  METHODS
  The primary endpoint was success rate in obtaining intraoperative watertight dural closure in subjects receiving PEG hydrogel sealant versus a control group of subjects receiving any standard method designed to provide intraoperative watertight closure. Subjects were evaluated at discharge and at 30 and 90 days postprocedure for cerebrospinal fluid leaks, surgical site infections, and adverse events.
  
  
  RESULTS
  Between May 2007 and May 2009, 98 subjects (74 PEG hydrogel spinal sealant, 24 control) were randomized at 14 clinical sites in the United States. Patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (98.6% vs. 79.2%, P = 0.003). No statistical differences were seen in postoperative cerebrospinal fluid, infection, and wound healing. No neurological deficits were seen attributable to the sealant.
  
  
  CONCLUSIONS
  The low-swell PEG hydrogel spinal sealant evaluated in this study has been proven safe and effective for providing watertight closure when used as an adjunct to sutured closure of intentional durotomies during spinal surgery. PEG hydrogel sealants have again proved superior to other standard of care technologies for safe, efficacious dural closure.
  
  
  METHODS
  2.
authors: *Washington University School of Medicine, St. Louis, MO †Stanford University Medical Center, Stanford, CA ‡University of Cincinnati/Mayfield Clinic, Cincinnati, OH §University of California Davis, Sacramento, CA ¶University of Virginia Health Systems, Charlottesville, VA ‖Vanderbilt University Medical Center, Nashville, TN **Medical College of Georgia, Augusta, GA ††Cleveland Clinic, Cleveland, OH ‡‡Virginia Commonwealth University, Richmond, VA §§The Ohio State University Medical Center; Columbus, OH; and ¶¶Dartmouth-Hitchcock Medical Center, Lebanon, NH.
authors: Neill M
authors: NM
authors: Wright
authors: Jon
authors: J
authors: Park
authors: John M
authors: JM
authors: Tew
authors: Kee D
authors: KD
authors: Kim
authors: Mark E
authors: ME
authors: Shaffrey
authors: Joseph
authors: J
authors: Cheng
authors: Haroon
authors: H
authors: Choudhri
authors: Ajit A
authors: AA
authors: Krishnaney
authors: R Scott
authors: RS
authors: Graham
authors: Ehud
authors: E
authors: Mendel
authors: Nathan
authors: N
authors: Simmons
mesh_terms: D000328:Adult; D065634:Cerebrospinal Fluid Leak / Q000517:prevention & control*; D004338:Drug Combinations; D004388:Dura Mater / Q000601:surgery*; D005260:Female; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate / Q000737:chemistry / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D016037:Single-Blind Method; D013131:Spine / Q000601:surgery; D013537:Sutures; D014014:Tissue Adhesives / Q000737:chemistry / Q000627:therapeutic use*; D058106:Wound Closure Techniques
chemical_list: D004338:Drug Combinations; C570829:DuraSeal spinal sealant; D009842:Oligopeptides; D014014:Tissue Adhesives; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; D011092:Polyethylene Glycols