The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery

Not Applicable

Withdrawn

• Conditions: CSF Leak
• Interventions: Device: Duragen with Collagen Hydrodel and ASCs

• Registration Number: NCT04503161
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-07
• Study Start: 2021-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-29
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age >/= 18
• Planned for skull base surgery
• Able to understand and willing to sign a written informed consent form

Read More

Exclusion Criteria

• active skull base infection
• no plan for DuraGen repair by operating surgeon

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydrogel recipient	Duragen with Collagen Hydrodel and ASCs	-

Primary Outcome Measures

Name	Time	Method
Rate of CSF leak	6 months active participation (date of surgery + 6 months follow up via chart review)

Secondary Outcome Measures

Name	Time	Method
Postoperative infection	6 months active participation (date of surgery + 6 months follow up via chart review)
Death	6 months active participation (date of surgery + 6 months follow up via chart review)
Length of hospital stay	6 months active participation (date of surgery + 6 months follow up via chart review)
Postoperative hematoma	6 months active participation (date of surgery + 6 months follow up via chart review)
Need for rehospitalization	6 months active participation (date of surgery + 6 months follow up via chart review)
Need for reoperation	6 months active participation (date of surgery + 6 months follow up via chart review)