CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
EVARREST™ Fibrin Sealant Patch +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01902459
NCT01902459Phase 4Completed
CompareCT.gov

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

Ethicon, Inc.·interventional·Posted Jul 18, 2013·Updated Jan 17, 2018

In Brief

A Phase 4 clinical trial evaluating EVARREST™ Fibrin Sealant Patch and Standard of Care for Hemorrhage and Soft Tissue Bleeding. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhage, Soft Tissue Bleeding
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 18, 2013
Enrollment StartJul 1, 2013
Primary CompletionAug 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.0 years ago

Interventions

EVARREST™ Fibrin Sealant Patchbiological

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.

Standard of Careother

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.