A Phase 2 interventional study of Fibrin Pad and SURGICEL™ in Hemostasis, sponsored by Ethicon, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-11.
Sponsored by Ethicon, Inc. · Phase 2, Interventional, and Treatment
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.
Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Fibrin Pad
SURGICEL™ Absorbable Hemostat
Device: SURGICEL™
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).
Absorbable hemostat
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.
Time frame: Intra-operative
Proportion of Subjects Achieving Hemostatic Success
The proportion of subjects achieving hemostatic success at 10 minutes following randomization
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Intra-operative
Incidence of Adverse Events
Time frame: 30 days (+14 days)
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
| Milestone | Fibrin Pad Randomized | SURGICEL™ Randomized | Fibrin Pad Non-randomized |
|---|---|---|---|
| Started | 60 | 30 | 51 |
| Completed | 56 | 26 | 44 |
| Not completed | 4 | 4 | 7 |
| Withdrew: Lost to follow-up | 0 | 2 | 2 |
| Withdrew: Death | 2 | 1 | 4 |
| Withdrew: Scheduling issue | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 1 |
Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.
| percentage of success | Fibrin Pad - Randomized | SURGICEL | Fibrin Pad - Non-Randomized |
|---|---|---|---|
| Proportion of Subjects Achieving Hemostatic Success | 98.3 | 53.3 | 98.0 |
The proportion of subjects achieving hemostatic success at 10 minutes following randomization
| percentage of success | Fibrin Pad - Randomized | SURGICEL | Fibrin Pad - Non-randomized |
|---|---|---|---|
| Proportion of Subjects Achieving Hemostatic Success | 98.3 | 73.3 | 100.0 |
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.
| percentage of treatment failure | Fibrin Pad - Randomized | SURGICEL | Fibrin Pad - Non-randomized |
|---|---|---|---|
| Incidence of Treatment Failures | 1.7 | 46.7 | 2.0 |
The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).
| percentage of particpants | Fibrin Pad - Randomized | SURGICEL | Fibrin Pad - Non-randomized |
|---|---|---|---|
| Incidence of Adverse Events That Are Potentially Related to Bleeding | 0 | 10 | 0 |
The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism
| percentage of participants | Fibrin Pad - Randomized | SURGICEL | Fibrin Pad - Non-randomized |
|---|---|---|---|
| Incidence of Adverse Events That Are Potentially Related to Thrombotic Events | 1.7 | 6.7 | 13.7 |
The types of events that were potentially related to transfusion exposure could have include hypocalcemia.
| percentage of particpants | Fibrin Pad - Randomized | SURGICEL | Fibrin Pad - Non-randomized |
|---|---|---|---|
| Incidence of Adverse Events Potentially Related to Transfusion Exposure | 0 | 0 | 0 |
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.
| participants | Fibrin Pad - Randomized | SURGICEL | Fibrin Pad - Non-randomized |
|---|---|---|---|
| Total Incidence of Re-treatment | 1 | 14 | 1 |
| No hemostasis at 4-minutes and re-treated | 1 | 12 | 1 |
| Achieved hemostasis at 4-mins and re-treated | 0 | 2 | 0 |
| % if participants with atleast one AE | Fibrin Pad All | SURGICEL™ Randomized |
|---|---|---|
| Incidence of Adverse Events | 94.6 | 90.0 |
Collected over 30-Days (+14 Days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fibrin Pad All | — | 40/111 (36%) | 105/111 (94.6%) |
| SURGICEL™ Randomized | — | 15/30 (50%) | 27/30 (90%) |
| Event | Fibrin Pad All | SURGICEL™ Randomized |
|---|---|---|
| POSTOPERATIVE ILEUSInjury, poisoning and procedural complications | 2/111 | 3/30 |
| BRONCHOPLEURAL FISTULARespiratory, thoracic and mediastinal disorders | 1/111 | 2/30 |
| DEHYDRATIONMetabolism and nutrition disorders | 5/111 | 0/30 |
| PULMONARY EMBOLISMRespiratory, thoracic and mediastinal disorders | 5/111 | 1/30 |
| LEUKOCYTOSISBlood and lymphatic system disorders | 0/111 | 1/30 |
| ACUTE MYOCARDIAL INFARCTIONCardiac disorders | 0/111 | 1/30 |
| ATRIAL FIBRILLATIONCardiac disorders | 0/111 | 1/30 |
| CARDIAC ARRESTCardiac disorders | 0/111 | 1/30 |
| GASTROINTESTINAL HAEMORRHAGEGastrointestinal disorders | 1/111 | 1/30 |
| IMPAIRED GASTRIC EMPTYINGGastrointestinal disorders | 0/111 | 1/30 |
| Event | Fibrin Pad All | SURGICEL™ Randomized |
|---|---|---|
| HYPOMAGNESAEMIAMetabolism and nutrition disorders | 44/111 | 15/30 |
| HYPOPHOSPHATAEMIAMetabolism and nutrition disorders | 24/111 | 15/30 |
| NAUSEAGastrointestinal disorders | 46/111 | 14/30 |
| PYREXIAGeneral disorders | 22/111 | 12/30 |
| HYPOCALCAEMIAMetabolism and nutrition disorders | 13/111 | 8/30 |
| HYPOKALAEMIAMetabolism and nutrition disorders | 29/111 | 8/30 |
| HYPERGLYCAEMIAMetabolism and nutrition disorders | 26/111 | 6/30 |
| ANAEMIABlood and lymphatic system disorders | 19/111 | 7/30 |
| ATELECTASISRespiratory, thoracic and mediastinal disorders | 20/111 | 6/30 |
| LEUKOCYTOSISBlood and lymphatic system disorders | 13/111 | 5/30 |
| Age, Categorical(Participants) | Fibrin Pad All | SURGICEL™ Randomized | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 63 | 21 | 84 |
| >=65 years | 48 | 9 | 57 |
| Sex: Female, Male(Participants) | Fibrin Pad All | SURGICEL™ Randomized | Total |
|---|---|---|---|
| Female | 42 | 10 | 52 |
| Male | 69 | 20 | 89 |
| Race (NIH/OMB)(Participants) | Fibrin Pad All | SURGICEL™ Randomized | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 21 | 5 | 26 |
| White | 90 | 23 | 113 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Fibrin Pad All | SURGICEL™ Randomized | Total |
|---|---|---|---|
| United States | 111 | 30 | 141 |
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Ethicon, Inc.