Abstract
Study Design: A nonrandomized, two-armed prospective study. Objective: Water-tight dural closure is paramount to the prevention of cerebrospinal fluid (CSF) leakage and associated complications. Synthetic polyethylene glycol (PEG) hydrogel has been used as an adjunct to sutured dural repair; however, its expansion postoperatively is a concern for neurological complications. A low-swell formulation of PEG sealant was introduced as DuraSeal Exact Spine Sealant System (DESS). A Post-Approval Study was performed primarily to evaluate the safety and efficacy of DESS for spinal dural repair compared to current alternatives, in a large patient population, reflecting a real-world practice. Methods: A total of 36 sites in the United States enrolled 429 patients treated with DESS as an adjunct to dural repair in the spinal sealant group and 406 patients treated with all other modalities in the control arm, from October 2011 to June 2016. The primary endpoint was the incidence of CSF leak within 90 days of operation. The secondary endpoints evaluated were deep surgical site infection and neurological serious adverse events. Results: The CSF leakage in the DESS group (6.6%) was not significantly different from the control group (6.5%) (p =.83), and there was no significant difference in the time to first leak. The two groups had no significant differences in deep surgical site infection (1.6% versus control 2.1%, p =.61) or proportion of subjects with neurological serious adverse events (2.9% versus control 1.6%, p =.516). Conclusions: DuraSeal Exact Spinal Sealant is safe when compared to current alternatives for spinal dural repair.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 272-278 |
| Number of pages | 7 |
| Journal | Global Spine Journal |
| Volume | 9 |
| Issue number | 3 |
| DOIs | |
| State | Published - May 1 2019 |
| Externally published | Yes |
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Keywords
- CSF leak
- DuraSeal
- cauda equina syndrome
- dural repair
- dural tears
- epidural
- pseudomeningocele
- spine sealant
ASJC Scopus subject areas
- Surgery
- Orthopedics and Sports Medicine
- Clinical Neurology
Cite this
DuraSeal Exact Is a Safe Adjunctive Treatment for Durotomy in Spine : Postapproval Study. / Kim, Kee D.; Ramanathan, Dinesh; Highsmith, Jason; Lavelle, William; Gerszten, Peter; Vale, Fernando; Wright, Neill.
In: Global Spine Journal, Vol. 9, No. 3, 01.05.2019, p. 272-278.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - DuraSeal Exact Is a Safe Adjunctive Treatment for Durotomy in Spine
T2 - Postapproval Study
AU - Kim, Kee D.
AU - Ramanathan, Dinesh
AU - Highsmith, Jason
AU - Lavelle, William
AU - Gerszten, Peter
AU - Vale, Fernando
AU - Wright, Neill
PY - 2019/5/1
Y1 - 2019/5/1
N2 - Study Design: A nonrandomized, two-armed prospective study. Objective: Water-tight dural closure is paramount to the prevention of cerebrospinal fluid (CSF) leakage and associated complications. Synthetic polyethylene glycol (PEG) hydrogel has been used as an adjunct to sutured dural repair; however, its expansion postoperatively is a concern for neurological complications. A low-swell formulation of PEG sealant was introduced as DuraSeal Exact Spine Sealant System (DESS). A Post-Approval Study was performed primarily to evaluate the safety and efficacy of DESS for spinal dural repair compared to current alternatives, in a large patient population, reflecting a real-world practice. Methods: A total of 36 sites in the United States enrolled 429 patients treated with DESS as an adjunct to dural repair in the spinal sealant group and 406 patients treated with all other modalities in the control arm, from October 2011 to June 2016. The primary endpoint was the incidence of CSF leak within 90 days of operation. The secondary endpoints evaluated were deep surgical site infection and neurological serious adverse events. Results: The CSF leakage in the DESS group (6.6%) was not significantly different from the control group (6.5%) (p =.83), and there was no significant difference in the time to first leak. The two groups had no significant differences in deep surgical site infection (1.6% versus control 2.1%, p =.61) or proportion of subjects with neurological serious adverse events (2.9% versus control 1.6%, p =.516). Conclusions: DuraSeal Exact Spinal Sealant is safe when compared to current alternatives for spinal dural repair.
AB - Study Design: A nonrandomized, two-armed prospective study. Objective: Water-tight dural closure is paramount to the prevention of cerebrospinal fluid (CSF) leakage and associated complications. Synthetic polyethylene glycol (PEG) hydrogel has been used as an adjunct to sutured dural repair; however, its expansion postoperatively is a concern for neurological complications. A low-swell formulation of PEG sealant was introduced as DuraSeal Exact Spine Sealant System (DESS). A Post-Approval Study was performed primarily to evaluate the safety and efficacy of DESS for spinal dural repair compared to current alternatives, in a large patient population, reflecting a real-world practice. Methods: A total of 36 sites in the United States enrolled 429 patients treated with DESS as an adjunct to dural repair in the spinal sealant group and 406 patients treated with all other modalities in the control arm, from October 2011 to June 2016. The primary endpoint was the incidence of CSF leak within 90 days of operation. The secondary endpoints evaluated were deep surgical site infection and neurological serious adverse events. Results: The CSF leakage in the DESS group (6.6%) was not significantly different from the control group (6.5%) (p =.83), and there was no significant difference in the time to first leak. The two groups had no significant differences in deep surgical site infection (1.6% versus control 2.1%, p =.61) or proportion of subjects with neurological serious adverse events (2.9% versus control 1.6%, p =.516). Conclusions: DuraSeal Exact Spinal Sealant is safe when compared to current alternatives for spinal dural repair.
KW - CSF leak
KW - DuraSeal
KW - cauda equina syndrome
KW - dural repair
KW - dural tears
KW - epidural
KW - pseudomeningocele
KW - spine sealant
UR - http://www.scopus.com/inward/record.url?scp=85067199164&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85067199164&partnerID=8YFLogxK
U2 - 10.1177/2192568218791150
DO - 10.1177/2192568218791150
M3 - Article
AN - SCOPUS:85067199164
VL - 9
SP - 272
EP - 278
JO - Global Spine Journal
JF - Global Spine Journal
SN - 2192-5682
IS - 3
ER -