Gastrointestinal Diseases
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.
Detailed description
This is a single blind, randomized, multi-center controlled study evaluating the safety and effectiveness of EVICEL® when used as an adjunct to gastrointestinal (GI) surgery.
Interventions
BIOLOGICALEVICEL Fibrin Sealant
Intraoperative
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects undergoing primary elective GI surgery * Subjects ≥ 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures
Exclusion criteria
* Avastin use within 30 days prior to surgery; * Known hypersensitivity to the human blood products or the components of the investigational product; * Female subjects who are pregnant or nursing; * Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of Gastrointestinal (GI) Leak | 40 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events | up to Day 90 |
| Incidence of GI Leak | 90 days |
| Incidence of Stricture | up to Day 90 |
Countries
Australia, Belgium, Canada, New Zealand, South Korea, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EVICEL Fibrin Sealant: Randomized EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
EVICEL Fibrin Sealant: Intraoperative | 84 |
| Standard of Care Standard surgical technique for GI anastomosis. | 89 |
| Experimental: EVICEL Fibrin Sealant: Non-Randomized EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
EVICEL Fibrin Sealant: Intraoperative | 41 |
| Total | 214 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Missed 90 day visit | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | EVICEL Fibrin Sealant: Randomized | Standard of Care | Experimental: EVICEL Fibrin Sealant: Non-Randomized | Total |
|---|---|---|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 11.1 | 62.5 years STANDARD_DEVIATION 10.8 | 62.0 years STANDARD_DEVIATION 12.2 | 61.8 years STANDARD_DEVIATION 11.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 21 Participants | 21 Participants | 8 Participants | 50 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 61 Participants | 65 Participants | 31 Participants | 157 Participants |
| Region of Enrollment Australia | 10 participants | 9 participants | 6 participants | 25 participants |
| Region of Enrollment Belgium | 17 participants | 17 participants | 3 participants | 37 participants |
| Region of Enrollment Canada | 2 participants | 2 participants | 4 participants | 8 participants |
| Region of Enrollment Korea, Republic of | 20 participants | 20 participants | 7 participants | 47 participants |
| Region of Enrollment New Zealand | 10 participants | 10 participants | 1 participants | 21 participants |
| Region of Enrollment United Kingdom | 10 participants | 14 participants | 7 participants | 31 participants |
| Region of Enrollment United States | 15 participants | 17 participants | 13 participants | 45 participants |
| Sex: Female, Male Female | 41 Participants | 33 Participants | 21 Participants | 95 Participants |
| Sex: Female, Male Male | 43 Participants | 56 Participants | 20 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 81 / 84 | 83 / 89 | 41 / 41 |
| serious Total, serious adverse events | 25 / 84 | 22 / 89 | 10 / 41 |
Outcome results
Primary
Absence of Gastrointestinal (GI) Leak
Time frame: 40 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVICEL Fibrin Sealant: Randomized | Absence of Gastrointestinal (GI) Leak | 72 participants |
| Standard of Care | Absence of Gastrointestinal (GI) Leak | 81 participants |
| Experimental: EVICEL Fibrin Sealant: Non-Randomized | Absence of Gastrointestinal (GI) Leak | 38 participants |
Secondary
Incidence of Adverse Events
Time frame: up to Day 90
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVICEL Fibrin Sealant: Randomized | Incidence of Adverse Events | 633 number of adverse events |
| Standard of Care | Incidence of Adverse Events | 735 number of adverse events |
| Experimental: EVICEL Fibrin Sealant: Non-Randomized | Incidence of Adverse Events | 347 number of adverse events |
Secondary
Incidence of GI Leak
Time frame: 90 days
Population: The primary endpoint was absence of leak (success) within 40 days. Any data missing was considered failures. 3 EVICEL and 2 SoC subjects had missing data. These subjects were considered failures for the primary endpoint. The secondary endpoint was incidence of leak within 90 days post operatively. Missing data was not assumed to be leaks.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVICEL Fibrin Sealant: Randomized | Incidence of GI Leak | 9 participants |
| Standard of Care | Incidence of GI Leak | 6 participants |
| Experimental: EVICEL Fibrin Sealant: Non-Randomized | Incidence of GI Leak | 3 participants |
Secondary
Incidence of Stricture
Time frame: up to Day 90
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVICEL Fibrin Sealant: Randomized | Incidence of Stricture | 2 participants |
| Standard of Care | Incidence of Stricture | 3 participants |
| Experimental: EVICEL Fibrin Sealant: Non-Randomized | Incidence of Stricture | 1 participants |