This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects. After application of either SURGICEL Powder or SURGICEL Original, the target bleeding site (TBS) will be assessed for hemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of final fascial closure on open surgery or port site closure in laparoscopic or thoracoscopic procedures. All enrolled subjects will be observed post-operatively through discharge and followed up at 30 days (+14 days) and at 6 months (+/-30 days) post-surgery via phone call or office visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
234
Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Powder, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.
Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Original, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.
Zhejiang Provincial People's Hospital
Hangzhou, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum Tower Hospital - Nanjing University Medical School
Nanjing, China
Ruijin Hospital - Shanghai Jiaotong University School of Medicine
Shanghai, China
Hemostatic Success at 5 Minutes
Percentage of subjects achieving hemostatic success at 5 minutes following study product application with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure
Time frame: From product application to 5 minutes following product application
Hemostatic Success at 3 Minutes
Percentage of subjects achieving hemostatic success at 3 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure
Time frame: From product application to 3 minutes following product application
Hemostatic Success at 10 Minutes
Percentage of subjects achieving hemostatic success at 10 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure
Time frame: From product application to 10 minutes following product application
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Shanghai Xinhua Hospital
Shanghai, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China