Status:
COMPLETED
The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)
Lead Sponsor:
Ethicon, LLC
Conditions:
Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Adult subjects aged ≥18 years requiring elective/non-emergent open or laparoscopic general, gynecological, or cardiothoracic surgical procedures.
- Subject or authorized representative has signed the approved Informed Consent.
- Subject(s) whose platelet count is ≥100,000 per microliter and International Normalized Ratio (INR) is \<1.5 prior to 24 hours of surgery.
- Presence of an appropriate TBS identified intra-operatively by the surgeon.
- Subject(s) undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to TBS identification and treatment.
Exclusion
- Female subjects who are pregnant or nursing.
- Subject on heparin within 12 hours prior to surgery, or oral Coumadin (warfarin) and/or Factor Xa inhibitors within 3 days prior to surgery.
- Subject on antiplatelet/P2Y12 inhibitors medication 5 days prior to surgery;
- Subject is currently participating or plans to participate in any other investigational product or drug trial without prior approval from the Sponsor.
- Subjects who are known, current alcohol and/or drug abusers.
- Subjects with any pre-operative findings identified by the surgeon that may preclude conduct of the study procedure.
- Subjects with any intra-operative findings identified by the surgeon that may preclude the use of study product.
- Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected; see Appendix 1).
- TBS is on arteries or veins where application of SURGICEL Powder would present a risk of introducing the study product into an open blood vessel.
- Major arterial or venous bleeding or major defects in arteries and veins.
- TBS where silver nitrate or any other escharotic chemicals have been applied.
- TBS is in, around, or in proximity to foramina in bone, or areas of bony
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2020
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT03783039
Start Date
January 15 2019
End Date
May 6 2020
Last Update
July 8 2021
Active Locations (6)
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1
Zhejiang Provincial People's Hospital
Hangzhou, China
2
Jiangsu Province Hospital
Nanjing, China
3
Nanjing Drum Tower Hospital - Nanjing University Medical School
Nanjing, China
4
Ruijin Hospital - Shanghai Jiaotong University School of Medicine
Shanghai, China