This project seeks to test whether a cell-seeded collagen hydrogel dressing can reduce CSF leak after skull base surgery. Normally, patients at risk for CSF leak are treated with a commercial collagen matrix called Duragen. In this study, our sterile, cGMP manufactured collagen hydrogel dressing will be seeded with the stromal vascular fraction (SVF) mechanically isolated from lipoaspirate taken intra-operatively. This SVF contains pro-regenerative adipose stem cells (ASCs). The ASC-seeded hydrogel will be used as a supplement to Duragen to reinforce the skull base closure. The goal is to establish safety as well as to secondarily evaluate for effectiveness in reducing CSF leak postoperatively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Duragen combined with collagen hydrogel and patient's stem cells
Rate of CSF leak
Time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
Length of hospital stay
Time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
Need for reoperation
Time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
Postoperative hematoma
Time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
Postoperative infection
Time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
Need for rehospitalization
Time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
Death
Time frame: 6 months active participation (date of surgery + 6 months follow up via chart review)
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