A Prospective Study Evaluating the Safety and Effectiveness of EVARREST® Fibrin Sealant Patch in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open, Abdominal, Retroperitoneal, Pelvic and Thoracic (non-cardiac) Surgery in Pediatric Patients

Ethicon Inc0 sites35 target enrollmentOctober 1, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Mild or moderate hepatic parenchyma or soft tissue bleeding duringopen, abdominal, retroperitoneal, pelvic and thoracic (non-cardiac) surgery
Sponsor: Ethicon Inc
Enrollment: 35
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

October 1, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Pre\-operative:
•1\. Pediatric subjects aged \=28 days (\=1 month) to \<18 years, requiring non\-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non\-cardiac) surgical procedures;
•i) The first 31 subjects to be enrolled will be subjects aged \=1 year to \<18
•ii) The next 4 subjects to be enrolled will be subjects aged \=28 days to \<1 year.
•2\. The subject’s parent/legal guardian must be willing to give permission for the subject to participate in the trial and provide written Informed Consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the pediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian’s written Informed Consent for the subject will be acceptable for the subject to be included in the study.
•Intra\-operative
•3\. Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra\-operatively by the surgeon;
•4\. Ability to firmly press trial treatment at TBS until 4 minutes after TBS identification.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 35

•Pre\-Operative:
•1\. Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
•2\. Female subjects, of childbearing age (i.e. adolescent), who are pregnant or nursing;
•3\. Subject is currently participating or plan to participate in any other investigational device or drug study without prior approval from the Sponsor;
•4\. Subjects who are known, current alcohol and/or drug abusers
•5\. Subjects admitted for trauma surgery
•6\. Subjects with any pre or intra\-operative findings identified by the surgeon that may preclude conduct of the study procedure.
•Intra\-operative
•7\. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
•8\. TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST to blood flow and pressure during healing and absorption of the product;