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Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion.
Sponsor: Polyclinique Bordeaux Nord Aquitaine
Summary
The aim of this study is to assess the efficacy of the ARISTA AH for restoring hemostasis following a long segment posterior spinal fusion.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-10-25
Completion Date
2025-02-01
Last Updated
2024-11-08
Healthy Volunteers
No
Interventions
Control Group
During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent).
ARISTA
During the surgical procedure, hemostasis will be achieved using the standard of care (electrocautery, pressure, ligature or any hemostatic agent). Before surgical wound closure, the corresponding amount of ARISTA-AH will be applied to completely cover the bleeding site : * 5g for 5 to 8 instrumented vertebra * 10g fo 9 or more instrumented vertebra
Locations (1)
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France