Conditions: Hemostasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 141
Healthy volunteers: no

Brief summary:
The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.

Detailed description:

Arms:
arm 1: None arm 2: SURGICEL™ Absorbable Hemostat

Interventions: intervention 1: Fibrin Pad intervention 2: SURGICEL™
Intervention descriptions: intervention 1: Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). intervention 2: Absorbable hemostat

Protocol document: