NCT01902459

EVARREST™ Fibrin Sealant Patch Post-Market Study

A Non-Investigational Post-Market Trial Using EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis in Soft Tissue Bleeding During Intra-Abdominal, Retroperitoneal, Pelvic and Non-Cardiac Thoracic Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal (stomach area), retroperitoneal (hip and stomach area), pelvic (hip area) and non-cardiac thoracic (chest area) surgery.

Detailed description

This is a randomized, controlled single-center study observing the clinical utility of EVARREST™ against standard of care (SoC) in controlling soft tissue bleeding. Standard of care will be manual compression (MC) with or without a topical absorbable hemostat (TAH) or any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her standard of care. All subjects will be followed post-operatively through discharge and at 30 (+/-14) days. Approximately 150 qualified subjects undergoing intra-abdominal, retroperitoneal, pelvic and non-cardiac thoracic surgery requiring adjunctive support for hemostasis for soft tissue bleeding will be enrolled in the study. Subjects will be randomized on a 1:1 basis, EVARREST™ vs. SoC.

Conditions

• Hemorrhage
• Soft Tissue Bleeding

Interventions

Type	Name	Description
BIOLOGICAL	EVARREST™ Fibrin Sealant Patch	EVARREST™ Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
OTHER	Standard of Care	Standard of Care will be manual compression (MC) with or without a topical absorbable hemostat (TAH) or any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her standard of care.

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2013-07-18
• Last updated: 2018-01-17
• Results posted: 2018-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study