Phase 2
N=141
The Fibrin Patch Soft Tissue Study
Hemostasis
Bottom Line
View on ClinicalTrials.gov: NCT00658723 ↗Enrolled (actual)
141
Serious AEs
39.0%
Results posted
Sep 2014
Primary outcome: Primary: Proportion of Subjects Achieving Hemostatic Success — 98.3; 53.3; 98.0 percentage of success
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fibrin Pad (Drug); SURGICEL™ (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ethicon, Inc.
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Achieving Hemostatic Success |
98.3; 73.3; 100.0 | — |
| SECONDARY Proportion of Subjects Achieving Hemostatic Success |
98.3; 73.3; 100.0 | — |
| SECONDARY Incidence of Treatment Failures |
1.7; 46.7; 2.0 | — |
| SECONDARY Incidence of Adverse Events That Are Potentially Related to Bleeding |
0; 10; 0 | — |
| SECONDARY Incidence of Adverse Events That Are Potentially Related to Thrombotic Events |
1.7; 6.7; 13.7 | — |
| SECONDARY Incidence of Adverse Events Potentially Related to Transfusion Exposure |
0; 0; 0 | — |
| SECONDARY Incidence of Re-treatment |
1; 14; 1; 1; 12; 1 | — |
| SECONDARY Incidence of Adverse Events |
94.6; 90.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects >= 18 years of age, requiring non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures
- Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified intraoperatively by the surgeon
- Subjects must be willing to participate in the study, and provide written informed consent
Exclusion Criteria
- Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
- Subject with TBS within an actively infected field
- Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine
- Subjects with known intolerance to blood products or to one of the components of the study product
- Subjects unwilling to receive blood products
- Subjects with immunodeficiency diseases (including known HIV)
- Subjects who are known, current alcohol and / or drug abusers
- Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
- Female subjects who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT00658723). 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.