At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 141 enrolled
Drug / intervention
Fibrin Pad +1 moredrug
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.
A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery
In Brief
A Phase 2 clinical trial evaluating Fibrin Pad and SURGICEL™ for Hemostasis. Completed, enrolled 141 participants across 11 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemostasis
CountriesUnited States
CollaboratorsOMRIX Biopharmaceuticals
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2008
First PostedApr 2008
Primary CompletionApr 2009
Study CompletionMay 2009
TodayJul 2026
First PostedApr 15, 2008
Enrollment StartMar 1, 2008
Primary CompletionApr 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.2 years ago
Interventions
Fibrin Paddrug
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).
SURGICEL™device
Absorbable hemostat