Phase 4
N=150
EVARREST™ Fibrin Sealant Patch Post-Market Study
Hemorrhage · Soft Tissue Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT01902459 ↗Enrolled (actual)
150
Serious AEs
6.7%
Results posted
Jan 2018
Primary outcome: Primary: Safety Parameter - Incidence of Thromboembolic Events — 2; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- EVARREST™ Fibrin Sealant Patch (Biological); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ethicon, Inc.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Parameter - Incidence of Thromboembolic Events |
2; 7 | — |
| PRIMARY Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS) |
0; 0 | — |
| PRIMARY Safety Parameter - Incidence of Increase Blood Fibrinogen Level |
3; 1 | — |
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.
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;
Data sourced from ClinicalTrials.gov (NCT01902459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.