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The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrin Pad | Experimental |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin Pad | Biological | Fibrin Pad 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving hemostasis at the Target Bleeding Site. Hemostasis is defined as no detectable bleeding at the TBS. | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving hemostatic success at 10 minutes following randomization | Intra-operative | |
| Absolute time to hemostasis | Intra-operative | |
| Proportion of subjects requiring re-treatment at the TBS prior to wound closure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Hart, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bankstown Hospital | Bankstown | Australia | ||||
| Flinders Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26216641 | Result | Koea J, Baldwin P, Shen J, Patel B, Batiller J, Arnaud A, Hart J, Hammond J, Fischer C, James Garden O. Erratum to: Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial. World J Surg. 2015 Oct;39(10):2610. doi: 10.1007/s00268-015-3163-9. No abstract available. | |
| 26041587 |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Procedure | Standard of Care is a composite of techniques/methods typically used by the surgeon to control severe bleeding. |
|
| Intra-operative |
| Incidence of treatment failures | Intra-operative |
| Incidence of adverse events that are potentially related to bleeding at the TBS | Intra-operative through 60 days |
| Incidence of adverse events that are potentially related to thrombotic events; | Intra-operative through 60 days |
| Incidence of adverse events | Intra-operative through 60 days |
| Bedford Park |
| Australia |
| The Townsville Hospital | Douglas | Australia |
| Royal Melbourne Hospital | Parkville | Australia |
| University Hospital of the University of Saarland | Homburg/Saar | Homburg/Saar | D-66421 | Germany |
| Department of Surgery, University of Heidelberg | Heidelberg | 69120 | Germany |
| Krankenhaus Salem | Heidelberg | 69121 | Germany |
| Vincentius-Klinken | Karlsruhe | Germany |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| Auckland City Hospital | Auckland | New Zealand |
| North Shore Hospital | Auckland | New Zealand |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| The Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| St. James University Hospital | Leeds | LS9 7TF | United Kingdom |
| St Bartholomew's Hospital | London | EC1A 2BE | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Result |
| Koea J, Baldwin P, Shen J, Patel B, Batiller J, Arnaud A, Hart J, Hammond J, Fischer C, James Garden O. Safety and Hemostatic Effectiveness of the Fibrin Pad for Severe Soft-Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic (Non-cardiac) Surgery: A Randomized, Controlled, Superiority Trial. World J Surg. 2015 Nov;39(11):2663-9. doi: 10.1007/s00268-015-3106-5. |
| 26636489 | Derived | Corral M, Ferko N, Hollmann S, Hogan A, Jamous N, Batiller J, Shen J. Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials. Curr Med Res Opin. 2016;32(2):367-75. doi: 10.1185/03007995.2015.1128405. Epub 2015 Dec 21. |