A Prospective, Randomized, Controlled, Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Hemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Pediatric Patients - The Paediatric EVICEL® Soft Tissue Bleeding Study

Ethicon Inc.0 个研究点目标入组 40 人开始时间: 2014年1月2日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Pre-operative:
•1. Paediatric subjects birth to < 18 years of age, requiring non-emergent laparoscopic or open abdominal, retroperitoneal, pelvic, or thoracic (non-cardiac) surgical procedures;
•2. The subject and/or subject’s parent or legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. If possible, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If
•the paediatric 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 parenchymal organ Target Bleeding Site identified intra-operatively by the surgeon;
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;
•3. Subject is currently participating or, during the study is planned to participate in any other investigational device or drug trial 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. Anastomotic bleeding sites will not be considered for randomization

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