The purpose of this study is to further assess the safety and performance of Seal-V as an adjunct to standard surgical procedure for achieving hemostasis in patients undergoing peripheral vascular reconstruction surgeries using synthetic grafts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Seal-V is applied adjunctively to cover the suture lines.
Department of Vascular Surgery, Bnai-Zion Medical Center
Haifa, Israel
Vascular Surgery Department, Rambam Health Care
Haifa, Israel
Department of Vascular Surgery, Chaim Sheba Medical Center
Tel Litwinsky, Israel
TTH, Time to Hemostasis
Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site
Time frame: Perioperative; within 10 minutes after clamp release
Successful cessation of bleeding at a treatment site
Time frame: Perioperative; within 10 minutes after clamp release
Intraoperative blood loss
Measured by weighing the surgical swabs used only in the application area and used from the time Seal-V was applied until hemostasis
Time frame: Perioperative
Incidence of successful deployment of the Seal-V device
Time frame: Perioperative
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