The Fibrin Patch Soft Tissue Study
- Registration Number
- NCT00658723
- Lead Sponsor
- Ethicon, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 SURGICEL™ SURGICEL™ Absorbable Hemostat 1 Fibrin Pad -
- Primary Outcome Measures
Name Time Method Proportion of Subjects Achieving Hemostatic Success Intra-operative Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.
- Secondary Outcome Measures
Name Time Method Proportion of Subjects Achieving Hemostatic Success 10 minutes The proportion of subjects achieving hemostatic success at 10 minutes following randomization
Incidence of Treatment Failures Intra-operative If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.
Incidence of Adverse Events That Are Potentially Related to Bleeding Intra-operative up to 1 month (+14 days) The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).
Incidence of Adverse Events Potentially Related to Transfusion Exposure Intra-operative up to 1 month (+14 days) The types of events that were potentially related to transfusion exposure could have include hypocalcemia.
Incidence of Adverse Events 30 days (+14 days) Incidence of Adverse Events That Are Potentially Related to Thrombotic Events Intra-operative up to 1 month (+14 days) The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism
Incidence of Re-treatment Intra-operative The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period.
In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment.
Trial Locations
- Locations (11)
University of Alabama
🇺🇸Birmingham, Alabama, United States
Baptist Hosptial
🇺🇸Miami, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Long Island Jewish Medical Center
🇺🇸NEw Hyde Park, New York, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Weill Medical Colleges of Cornell University - Methodist Hospital
🇺🇸Houston, Texas, United States
St. Agnes Healthcare, Inc.
🇺🇸Baltimore, Maryland, United States