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

Joshua W. Osbun, Richard G. Ellenbogen, Randall M. Chesnut, Lawrence S. Chin, Patrick J. Connolly, G. Rees Cosgrove, Johnny B. Delashaw, John G. Golfinos, Jeremy D W Greenlee, Stephen J. Haines, Jack Jallo, J. Paul Muizelaar, Anil Nanda, Mark Shaffrey, Mitesh V. Shah, John M. Tew, Harry R. Van Loveren, Martin E. Weinand, Jonathan A. White, James E. Wilberger

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

Objective: 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. Methods: 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. Results: 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 < 0.001). The dural augmentation was applied in less than 1 minute in 85.7% of the PEG hydrogel group compared with 66.4% of the control group (P < 0.001). Conclusions: The PEG hydrogel dural sealant used in this study has a similar safety profile to commonly used dural sealing techniques when used as dural closure augmentation in cranial surgery. The PEG hydrogel dural sealant demonstrated faster preparation and application times than other commonly used dural sealing techniques.

Original languageEnglish (US)
Pages (from-to)498-504
Number of pages7
JournalWorld Neurosurgery
Volume78
Issue number5
DOIs
StatePublished - Nov 2012

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Hydrogel
Safety
Surgical Wound Infection
Incidence
United States Food and Drug Administration
Control Groups
Valsalva Maneuver
Fibrin Tissue Adhesive
Porifera
Wound Infection
Gelatin
Standard of Care
Reoperation
Meningitis
Wound Healing
Sutures
Collagen
Cerebrospinal Fluid Leak
Prospective Studies
Morbidity

Keywords

  • Cranial surgery
  • CSF leak
  • Dural sealant
  • DuraSeal
  • PEG hydrogel

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery

Cite this

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. / Osbun, Joshua W.; Ellenbogen, Richard G.; Chesnut, Randall M.; Chin, Lawrence S.; Connolly, Patrick J.; Cosgrove, G. Rees; Delashaw, Johnny B.; Golfinos, John G.; Greenlee, Jeremy D W; Haines, Stephen J.; Jallo, Jack; Muizelaar, J. Paul; Nanda, Anil; Shaffrey, Mark; Shah, Mitesh V.; Tew, John M.; Van Loveren, Harry R.; Weinand, Martin E.; White, Jonathan A.; Wilberger, James E.

In: World Neurosurgery, Vol. 78, No. 5, 11.2012, p. 498-504.

Research output: Contribution to journalArticle

Osbun, JW, Ellenbogen, RG, Chesnut, RM, Chin, LS, Connolly, PJ, Cosgrove, GR, Delashaw, JB, Golfinos, JG, Greenlee, JDW, Haines, SJ, Jallo, J, Muizelaar, JP, Nanda, A, Shaffrey, M, Shah, MV, Tew, JM, Van Loveren, HR, Weinand, ME, White, JA & Wilberger, JE 2012, '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', World Neurosurgery, vol. 78, no. 5, pp. 498-504. https://doi.org/10.1016/j.wneu.2011.12.011
Osbun, Joshua W. ; Ellenbogen, Richard G. ; Chesnut, Randall M. ; Chin, Lawrence S. ; Connolly, Patrick J. ; Cosgrove, G. Rees ; Delashaw, Johnny B. ; Golfinos, John G. ; Greenlee, Jeremy D W ; Haines, Stephen J. ; Jallo, Jack ; Muizelaar, J. Paul ; Nanda, Anil ; Shaffrey, Mark ; Shah, Mitesh V. ; Tew, John M. ; Van Loveren, Harry R. ; Weinand, Martin E. ; White, Jonathan A. ; Wilberger, James E. / 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. In: World Neurosurgery. 2012 ; Vol. 78, No. 5. pp. 498-504.
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abstract = "Objective: 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. Methods: 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. Results: 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 < 0.001). The dural augmentation was applied in less than 1 minute in 85.7{\%} of the PEG hydrogel group compared with 66.4{\%} of the control group (P < 0.001). Conclusions: The PEG hydrogel dural sealant used in this study has a similar safety profile to commonly used dural sealing techniques when used as dural closure augmentation in cranial surgery. The PEG hydrogel dural sealant demonstrated faster preparation and application times than other commonly used dural sealing techniques.",
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TY - JOUR

T1 - 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

AU - Osbun, Joshua W.

AU - Ellenbogen, Richard G.

AU - Chesnut, Randall M.

AU - Chin, Lawrence S.

AU - Connolly, Patrick J.

AU - Cosgrove, G. Rees

AU - Delashaw, Johnny B.

AU - Golfinos, John G.

AU - Greenlee, Jeremy D W

AU - Haines, Stephen J.

AU - Jallo, Jack

AU - Muizelaar, J. Paul

AU - Nanda, Anil

AU - Shaffrey, Mark

AU - Shah, Mitesh V.

AU - Tew, John M.

AU - Van Loveren, Harry R.

AU - Weinand, Martin E.

AU - White, Jonathan A.

AU - Wilberger, James E.

PY - 2012/11

Y1 - 2012/11

N2 - Objective: 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. Methods: 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. Results: 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 < 0.001). The dural augmentation was applied in less than 1 minute in 85.7% of the PEG hydrogel group compared with 66.4% of the control group (P < 0.001). Conclusions: The PEG hydrogel dural sealant used in this study has a similar safety profile to commonly used dural sealing techniques when used as dural closure augmentation in cranial surgery. The PEG hydrogel dural sealant demonstrated faster preparation and application times than other commonly used dural sealing techniques.

AB - Objective: 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. Methods: 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. Results: 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 < 0.001). The dural augmentation was applied in less than 1 minute in 85.7% of the PEG hydrogel group compared with 66.4% of the control group (P < 0.001). Conclusions: The PEG hydrogel dural sealant used in this study has a similar safety profile to commonly used dural sealing techniques when used as dural closure augmentation in cranial surgery. The PEG hydrogel dural sealant demonstrated faster preparation and application times than other commonly used dural sealing techniques.

KW - Cranial surgery

KW - CSF leak

KW - Dural sealant

KW - DuraSeal

KW - PEG hydrogel

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