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N/A N=234 Randomized Single-blind Treatment

The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)

Hemorrhage

Enrolled (actual)
234
Serious AEs
6.0%
Results posted
Dec 2020
Primary outcome: Primary: Hemostatic Success at 5 Minutes — 109; 103 Participants — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SURGICEL Powder (Device); SURGICEL Original (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Ethicon, LLC
Primary completion
Dec 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Hemostatic Success at 5 Minutes
109; 103 <0.0001 sig
SECONDARY
Hemostatic Success at 3 Minutes
107; 92
SECONDARY
Hemostatic Success at 10 Minutes
114; 107

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 arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03783039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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