To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
252
Clinical Investigation Site #21
Guangzhou, Guangdong, China
Clinical Investigation Site #32
Nanjing, Jiangsu, China
Clinical Investigation Site #31
Nanjing, Jiangsu, China
Clinical Investigation Site #30
Jinan, Shandong, China
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.
Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.
Time frame: Intra-operative, 10 minutes following randomization
Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application
Percentage of participants with Hemostasis at the TBS at 3 and 6 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.
Time frame: Intra-operative, 3 and 6 minutes following randomization
Number of Participants Requiring Alternative Treatment Due to Treatment Failure*
Alternative treatments include the use of additional hemostatic methods, including collagen, manual compression, oxidized regenerated cellulose and suture. Manual compression (MC) may be applied after the initial 10 minute observation period as an alternative treatment due to treatment failure in either group. For participants with a treatment failure in MC group, the addition treatment of MC is applied after the initial 10 minute observation period.
Time frame: Intra-operative, 10 minutes following randomization
Percentage of Participants With Potential Bleeding-related Adverse Events
Percentage of participants with potential bleeding-related adverse events by study group
Time frame: 30-days follow-up
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Clinical Investigation Site #22
Chengdu, Sichuan, China
Clinical Investigation Site #26
Beijing, China
Clinical Investigation Site #28
Beijing, China
Clinical Investigation Site #25
Shanghai, China
Clinical Investigation Site #23
Shanghai, China