Clinical trial NCT01902459: EVARREST™ Fibrin Sealant Patch Post-Market Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhage
Soft Tissue Bleeding
Keywords: Hemostasis
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subjects ≥18 years of age, requiring an elective or urgent, open intra-abdominal, retroperitoneal, pelvic or non-cardiac thoracic surgical procedures;
* Subjects or legally authorized representative must be willing to participate in the study and provide written informed consent.
* Presence of an appropriate Target Bleeding Site as identified intra-operatively by the surgeon;

Exclusion Criteria:

* Subjects with known intolerance to blood products or to one of the components of EVARREST™ or unwilling to receive blood products;
* Female subjects who are pregnant or nursing.
* TBS is from a large defect in an artery or vein where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ to blood flow and/or pressure during absorption of the product;
* TBS with major arterial bleeding requiring suture or mechanical ligation;
* TBS within a contaminated or infected area of the body;
* Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
* Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;

Primary outcomes:
measure: Safety Parameter - Incidence of Thromboembolic Events
timeFrame: Surgery up until the 30 day follow-up
measure: Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS)
timeFrame: Surgery up until the 30 day follow-up
measure: Safety Parameter - Incidence of Increase Blood Fibrinogen Level
timeFrame: Surgery up until the 30 day follow-up
Secondary outcomes:
Other outcomes:
measure: This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.
timeFrame: Intraoperative
measure: This Product is Easy to Apply to a Variety of Bleeding Sites.
timeFrame: Intraoperative
measure: This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.
timeFrame: Intraoperative
Locations:
city: Saint Louis
country: United States
facility: Clinical Site #10
state: Missouri
Study officials:
affiliation: Ethicon, Inc.
name: Richard Kocharian, MD
role: STUDY_DIRECTOR
References: