Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| OMRIX Biopharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator | SURGICEL™ Absorbable Hemostat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin Pad | Drug | Fibrin Patch 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 Hemostatic Success | Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period. | Intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Achieving Hemostatic Success | The proportion of subjects achieving hemostatic success at 10 minutes following randomization | 10 minutes |
| Incidence of Treatment Failures | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Hart, M.D. | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Jacksonville Center for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23969113 | Result | Fischer CP, Bochicchio G, Shen J, Patel B, Batiller J, Hart JC. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93. doi: 10.1016/j.jamcollsurg.2013.02.036. | |
| 26636489 |
Not provided
Not provided
The efficacy results are based on the intent-to-treat (ITT) set, which is based on 90 randomized subjects from the two randomized arms - Fibrin Pad Randomized and SURGICEL(TM) Randomized. The Fibrin Pad Non-randomized arm was used for the safety analysis set.
A total of 11 clinical centers in the US partipcated in the trial enrolled 141 subjects. The first subject randomized: March 26, 2008 and the last subject completed: April 24, 2009
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fibrin Pad Randomized | Fibrin Pad: Fibrin Patch 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). - Randomized |
| FG001 | SURGICEL™ Randomized | SURGICEL™ Absorbable Hemostat SURGICEL™: Absorbable hemostat |
| FG002 | Fibrin Pad Non-randomized | Fibrin Pad: Fibrin Patch 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). (Non - Randomized) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fibrin Pad All | Fibrin Pad: Fibrin Patch 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). - Randomized & Non Randomized |
| BG001 | SURGICEL™ Randomized |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects Achieving Hemostatic Success | Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period. | Posted | Number | percentage of success | Intra-operative |
|
30-Days (+14 Days)
Adverse Events were collected starting at randomization until 30 day follow-up visit (30-Days (+ 14 days))
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fibrin Pad All | Fibrin Pad: Fibrin Patch 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). - Randomized & Non Randomized |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Batiller, Director Clinical Development | ETHICON, Inc. | 908-218-2819 | JBatill2@its.jnj.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SURGICEL™ | Device | Absorbable hemostat |
|
| Intra-operative |
| Incidence of Adverse Events That Are Potentially Related to Bleeding | The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS). | Intra-operative up to 1 month (+14 days) |
| Incidence of Adverse Events That Are Potentially Related to Thrombotic Events | The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism | Intra-operative up to 1 month (+14 days) |
| Incidence of Adverse Events Potentially Related to Transfusion Exposure | The types of events that were potentially related to transfusion exposure could have include hypocalcemia. | Intra-operative up to 1 month (+14 days) |
| Incidence of Re-treatment | 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. | Intra-operative |
| Incidence of Adverse Events | 30 days (+14 days) |
| Jacksonville |
| Florida |
| 32216 |
| United States |
| Baptist Hosptial | Miami | Florida | 33173 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| St. Agnes Healthcare, Inc. | Baltimore | Maryland | 21229 | United States |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Weill Medical Colleges of Cornell University - Methodist Hospital | Houston | Texas | 77030 | United States |
| 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. |
| Scheduling Issue |
|
| Withdrawal by Subject |
|
SURGICEL™ Absorbable Hemostat |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fibrin Pad - Non-Randomized |
Fibrin Pad: Fibrin Patch 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). - Non-Randomized |
|
|
| Secondary | Proportion of Subjects Achieving Hemostatic Success | The proportion of subjects achieving hemostatic success at 10 minutes following randomization | Posted | Number | percentage of success | 10 minutes |
|
|
|
| Secondary | Incidence of Treatment Failures | 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. | Posted | Number | percentage of treatment failure | Intra-operative |
|
|
|
| Secondary | Incidence of Adverse Events That Are Potentially Related to Bleeding | The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS). | Posted | Number | percentage of particpants | Intra-operative up to 1 month (+14 days) |
|
|
|
| Secondary | Incidence of Adverse Events That Are Potentially Related to Thrombotic Events | The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism | Posted | Number | percentage of participants | Intra-operative up to 1 month (+14 days) |
|
|
|
| Secondary | Incidence of Adverse Events Potentially Related to Transfusion Exposure | The types of events that were potentially related to transfusion exposure could have include hypocalcemia. | Posted | Number | percentage of particpants | Intra-operative up to 1 month (+14 days) |
|
|
|
| Secondary | Incidence of Re-treatment | 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. | Posted | Number | participants | Intra-operative |
|
|
|
| Secondary | Incidence of Adverse Events | Posted | Number | % if participants with atleast one AE | 30 days (+14 days) |
|
|
|
| 40 |
| 111 |
| 105 |
| 111 |
| EG001 | SURGICEL™ Randomized | SURGICEL™ Absorbable Hemostat | 15 | 30 | 27 | 30 |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | Systematic Assessment |
|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | Systematic Assessment |
|
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
|
| VENTRICULAR TACHYCARDIA | Cardiac disorders | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | Systematic Assessment |
|
| GASTROINTESTINAL HYPOMOTILITY | Gastrointestinal disorders | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | Systematic Assessment |
|
| IMPAIRED GASTRIC EMPTYING | Gastrointestinal disorders | Systematic Assessment |
|
| INTESTINAL INFARCTION | Gastrointestinal disorders | Systematic Assessment |
|
| INTESTINAL PERFORATION | Gastrointestinal disorders | Systematic Assessment |
|
| LOCALISED INTRAABDOMINAL FLUID COLLECTION | Gastrointestinal disorders | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
|
| OESOPHAGEAL PERFORATION | Gastrointestinal disorders | Systematic Assessment |
|
| PANCREATIC FISTULA | Gastrointestinal disorders | Systematic Assessment |
|
| RETROPERITONEAL HAEMORRHAGE | Gastrointestinal disorders | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Systematic Assessment |
|
| PYREXIA | General disorders | Systematic Assessment |
|
| ANAPHYLACTIC REACTION | Immune system disorders | Systematic Assessment |
|
| ABDOMINAL ABSCESS | Infections and infestations | Systematic Assessment |
|
| ABSCESS | Infections and infestations | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | Systematic Assessment |
|
| EMPYEMA | Infections and infestations | Systematic Assessment |
|
| LIVER ABSCESS | Infections and infestations | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | Systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | Systematic Assessment |
|
| ABDOMINAL WOUND DEHISCENCE | Injury, poisoning and procedural complications | Systematic Assessment |
|
| GASTROINTESTINAL STOMA COMPLICATION | Injury, poisoning and procedural complications | Systematic Assessment |
|
| OPERATIVE HAEMORRHAGE | Injury, poisoning and procedural complications | Systematic Assessment |
|
| PERIPANCREATIC FLUID COLLECTION | Injury, poisoning and procedural complications | Systematic Assessment |
|
| POSTOPERATIVE ILEUS | Injury, poisoning and procedural complications | Systematic Assessment |
|
| BODY TEMPERATURE INCREASED | Investigations | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | Systematic Assessment |
|
| FAILURE TO THRIVE | Metabolism and nutrition disorders | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| FISTULA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | Systematic Assessment |
|
| ALCOHOL WITHDRAWAL SYNDROME | Psychiatric disorders | Systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | Systematic Assessment |
|
| URINARY RETENTION | Renal and urinary disorders | Systematic Assessment |
|
| ACUTE RESPIRATORY DISTRESS SYNDROME | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| BRONCHOPLEURAL FISTULA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| SUBCUTANEOUS EMPHYSEMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | Systematic Assessment |
|
| EMBOLISM | Vascular disorders | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | Systematic Assessment |
|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Systematic Assessment |
|
| CHEST PAIN | General disorders | Systematic Assessment |
|
| OEDEMA | General disorders | Systematic Assessment |
|
| PAIN | General disorders | Systematic Assessment |
|
| PYREXIA | General disorders | Systematic Assessment |
|
| ABDOMINAL ABSCESS | Infections and infestations | Systematic Assessment |
|
| ABDOMINAL INFECTION | Infections and infestations | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | Systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | Systematic Assessment |
|
| OPERATIVE HAEMORRHAGE | Injury, poisoning and procedural complications | Systematic Assessment |
|
| POSTOPERATIVE ILEUS | Injury, poisoning and procedural complications | Systematic Assessment |
|
| PROCEDURAL HYPOTENSION | Injury, poisoning and procedural complications | Systematic Assessment |
|
| URINE OUTPUT DECREASED | Investigations | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | Systematic Assessment |
|
| FLUID OVERLOAD | Metabolism and nutrition disorders | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
|
| HYPOCALCAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
|
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
|
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
|
| HYPOVOLAEMIA | Metabolism and nutrition disorders | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | Systematic Assessment |
|
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| BRONCHOPLEURAL FISTULA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PULMONARY OEDEMA | Social circumstances | Systematic Assessment |
|
| RHONCHI | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SUBCUTANEOUS EMPHYSEMA | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | Systematic Assessment |
|
Not provided
|
| Achieved hemostasis at 4-mins and re-treated |
|