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The EVICEL® Gastrointestinal Study

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ClinicalTrials.gov Identifier: NCT01589822
Recruitment Status : Completed
First Posted : May 2, 2012
Results First Posted : February 25, 2015
Last Update Posted : February 25, 2015
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Gastrointestinal Diseases
Intervention Biological: EVICEL Fibrin Sealant
Enrollment 214
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EVICEL Fibrin Sealant: Randomized Standard of Care Experimental: EVICEL Fibrin Sealant: Non-Randomized
Hide Arm/Group Description

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.

EVICEL Fibrin Sealant: Intraoperative

Standard surgical technique for GI anastomosis.

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

EVICEL Fibrin Sealant: Intraoperative

Period Title: Overall Study
Started 84 89 41
Completed 80 86 40
Not Completed 4 3 1
Reason Not Completed
Withdrawal by Subject             1             2             0
Death             1             0             0
Missed 90 day visit             2             1             1
Arm/Group Title EVICEL Fibrin Sealant: Randomized Standard of Care Experimental: EVICEL Fibrin Sealant: Non-Randomized Total
Hide Arm/Group Description

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.

EVICEL Fibrin Sealant: Intraoperative

Standard surgical technique for GI anastomosis.

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

EVICEL Fibrin Sealant: Intraoperative

Total of all reporting groups
Overall Number of Baseline Participants 84 89 41 214
Hide Baseline Analysis Population Description
Subjects enrolled who consented and were randomized into the study or assigned to the non-randomized portion and had the investigational product applied were included in the analysis sets. The Safety Set consists of 125 subjects treated with EVICEL (41 Non- Randomized) and 89 subjects treated with Standard of Care.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants 89 participants 41 participants 214 participants
61.1  (11.1) 62.5  (10.8) 62.0  (12.2) 61.8  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 89 participants 41 participants 214 participants
Female
41
  48.8%
33
  37.1%
21
  51.2%
95
  44.4%
Male
43
  51.2%
56
  62.9%
20
  48.8%
119
  55.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 89 participants 41 participants 214 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
21
  25.0%
21
  23.6%
8
  19.5%
50
  23.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   2.4%
1
   0.5%
White
61
  72.6%
65
  73.0%
31
  75.6%
157
  73.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   2.4%
3
   3.4%
1
   2.4%
6
   2.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 84 participants 89 participants 41 participants 214 participants
United States 15 17 13 45
Canada 2 2 4 8
Belgium 17 17 3 37
Australia 10 9 6 25
New Zealand 10 10 1 21
United Kingdom 10 14 7 31
Korea, Republic of 20 20 7 47
1.Primary Outcome
Title Absence of Gastrointestinal (GI) Leak
Hide Description [Not Specified]
Time Frame 40 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EVICEL Fibrin Sealant: Randomized Standard of Care Experimental: EVICEL Fibrin Sealant: Non-Randomized
Hide Arm/Group Description:

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.

EVICEL Fibrin Sealant: Intraoperative (IIT)

Standard surgical technique for GI anastomosis. (IIT)

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

EVICEL Fibrin Sealant: Intraoperative (Safety Set)

Overall Number of Participants Analyzed 84 89 41
Measure Type: Number
Unit of Measure: participants
72 81 38
2.Secondary Outcome
Title Incidence of Adverse Events
Hide Description [Not Specified]
Time Frame up to Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EVICEL Fibrin Sealant: Randomized Standard of Care Experimental: EVICEL Fibrin Sealant: Non-Randomized
Hide Arm/Group Description:

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.

EVICEL Fibrin Sealant: Intraoperative (Safety Set)

Standard surgical technique for GI anastomosis. (Safety Set)

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

EVICEL Fibrin Sealant: Intraoperative (Safety Set)

Overall Number of Participants Analyzed 84 89 41
Measure Type: Number
Unit of Measure: number of adverse events
633 735 347
3.Secondary Outcome
Title Incidence of GI Leak
Hide Description [Not Specified]
Time Frame 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title EVICEL Fibrin Sealant: Randomized Standard of Care Experimental: EVICEL Fibrin Sealant: Non-Randomized
Hide Arm/Group Description:

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.

EVICEL Fibrin Sealant: Intraoperative (Safety Set)

Standard surgical technique for GI anastomosis. (Safety Set)

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

EVICEL Fibrin Sealant: Intraoperative (Safety Set)

Overall Number of Participants Analyzed 84 89 41
Measure Type: Number
Unit of Measure: participants
9 6 3
4.Secondary Outcome
Title Incidence of Stricture
Hide Description [Not Specified]
Time Frame up to Day 90
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EVICEL Fibrin Sealant: Randomized Standard of Care Experimental: EVICEL Fibrin Sealant: Non-Randomized
Hide Arm/Group Description:

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.

EVICEL Fibrin Sealant: Intraoperative (Safety Set)

Standard surgical technique for GI anastomosis. (Safety Set)

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

EVICEL Fibrin Sealant: Intraoperative (Safety Set)

Overall Number of Participants Analyzed 84 89 41
Measure Type: Number
Unit of Measure: participants
2 3 1
Time Frame AEs occurring up to study Day-90
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EVICEL Fibrin Sealant: Randomized Standard of Care Experimental: EVICEL Fibrin Sealant: Non-Randomized
Hide Arm/Group Description

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.

EVICEL Fibrin Sealant: Intraoperative (Safety Set)

Standard surgical technique for GI anastomosis. (Safety Set)

EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen

EVICEL Fibrin Sealant: Intraoperative (Safety Set)

All-Cause Mortality
EVICEL Fibrin Sealant: Randomized Standard of Care Experimental: EVICEL Fibrin Sealant: Non-Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
EVICEL Fibrin Sealant: Randomized Standard of Care Experimental: EVICEL Fibrin Sealant: Non-Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/84 (29.76%)   22/89 (24.72%)   10/41 (24.39%) 
Cardiac disorders       
ACUTE MYOCARDIAL INFARCTION  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
ANGINA UNSTABLE  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
ATRIOVENTRICULAR BLOCK COMPLETE  0/84 (0.00%)  0/89 (0.00%)  1/41 (2.44%) 
CARDIAC ARREST  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
Gastrointestinal disorders       
ABDOMINAL PAIN  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
COLITIS  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
CONSTIPATION  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
DIARRHOEA  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
ENTEROCUTANEOUS FISTULA  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
ILEUS  3/84 (3.57%)  2/89 (2.25%)  0/41 (0.00%) 
ILEUS PARALYTIC  1/84 (1.19%)  1/89 (1.12%)  0/41 (0.00%) 
INTESTINAL OBSTRUCTION  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
INTESTINAL PERFORATION  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
RECTAL HAEMORRHAGE  0/84 (0.00%)  0/89 (0.00%)  1/41 (2.44%) 
SMALL INTESTINAL OBSTRUCTION  0/84 (0.00%)  2/89 (2.25%)  0/41 (0.00%) 
SMALL INTESTINAL PERFORATION  0/84 (0.00%)  1/89 (1.12%)  1/41 (2.44%) 
General disorders       
CHEST PAIN  0/84 (0.00%)  0/89 (0.00%)  1/41 (2.44%) 
PYREXIA  2/84 (2.38%)  0/89 (0.00%)  0/41 (0.00%) 
Hepatobiliary disorders       
PORTAL VEIN THROMBOSIS  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
Infections and infestations       
ABDOMINAL INFECTION  0/84 (0.00%)  0/89 (0.00%)  1/41 (2.44%) 
ABDOMINAL SEPSIS  2/84 (2.38%)  2/89 (2.25%)  1/41 (2.44%) 
ABSCESS  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
CELLULITIS  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
ENDOCARDITIS  0/84 (0.00%)  0/89 (0.00%)  1/41 (2.44%) 
GASTROENTERITIS  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
HAEMATOMA INFECTION  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
INFECTIOUS PERITONITIS  2/84 (2.38%)  0/89 (0.00%)  0/41 (0.00%) 
LIVER ABSCESS  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
NECROTISING FASCIITIS  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
PELVIC ABSCESS  2/84 (2.38%)  2/89 (2.25%)  0/41 (0.00%) 
PERITONITIS  2/84 (2.38%)  3/89 (3.37%)  0/41 (0.00%) 
PYELONEPHRITIS  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
PYELONEPHRITIS ACUTE  0/84 (0.00%)  0/89 (0.00%)  1/41 (2.44%) 
URINARY TRACT INFECTION  0/84 (0.00%)  3/89 (3.37%)  0/41 (0.00%) 
Injury, poisoning and procedural complications       
ANASTOMOTIC HAEMORRHAGE  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
ANASTOMOTIC LEAK  9/84 (10.71%)  6/89 (6.74%)  3/41 (7.32%) 
ANASTOMOTIC STENOSIS  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
INTESTINAL ANASTOMOSIS COMPLICATION  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
POSTOPERATIVE ILEUS  0/84 (0.00%)  3/89 (3.37%)  0/41 (0.00%) 
WOUND COMPLICATION  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
WOUND DEHISCENCE  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
WOUND EVISCERATION  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
Investigations       
BLOOD MAGNESIUM DECREASED  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
Metabolism and nutrition disorders       
DEHYDRATION  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
BREAST CANCER  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
URETHRAL CANCER  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
Nervous system disorders       
CRITICAL ILLNESS POLYNEUROPATHY  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
Psychiatric disorders       
CONFUSIONAL STATE  0/84 (0.00%)  0/89 (0.00%)  1/41 (2.44%) 
DEPRESSION  1/84 (1.19%)  0/89 (0.00%)  1/41 (2.44%) 
Renal and urinary disorders       
RENAL FAILURE ACUTE  1/84 (1.19%)  1/89 (1.12%)  0/41 (0.00%) 
URETERIC STENOSIS  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
URETHRAL STENOSIS  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
Reproductive system and breast disorders       
BENIGN PROSTATIC HYPERPLASIA  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
PELVIC HAEMATOMA  0/84 (0.00%)  0/89 (0.00%)  1/41 (2.44%) 
BRONCHIAL SECRETION RETENTION  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
HICCUPS  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
PLEURAL EFFUSION  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
RESPIRATORY ARREST  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
RESPIRATORY FAILURE  1/84 (1.19%)  1/89 (1.12%)  0/41 (0.00%) 
Skin and subcutaneous tissue disorders       
RASH MACULO-PAPULAR  1/84 (1.19%)  0/89 (0.00%)  0/41 (0.00%) 
Surgical and medical procedures       
ABSCESS DRAINAGE  0/84 (0.00%)  1/89 (1.12%)  0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
EVICEL Fibrin Sealant: Randomized Standard of Care Experimental: EVICEL Fibrin Sealant: Non-Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   81/84 (96.43%)   83/89 (93.26%)   41/41 (100.00%) 
Blood and lymphatic system disorders       
ANAEMIA  3/84 (3.57%)  5/89 (5.62%)  4/41 (9.76%) 
Cardiac disorders       
TACHYCARDIA  6/84 (7.14%)  12/89 (13.48%)  4/41 (9.76%) 
ILEUS  6/84 (7.14%)  5/89 (5.62%)  1/41 (2.44%) 
Gastrointestinal disorders       
ABDOMINAL DISTENSION  12/84 (14.29%)  17/89 (19.10%)  5/41 (12.20%) 
ABDOMINAL PAIN  17/84 (20.24%)  17/89 (19.10%)  8/41 (19.51%) 
CONSTIPATION  14/84 (16.67%)  17/89 (19.10%)  11/41 (26.83%) 
DIARRHOEA  11/84 (13.10%)  15/89 (16.85%)  8/41 (19.51%) 
NAUSEA  42/84 (50.00%)  47/89 (52.81%)  22/41 (53.66%) 
PROCTALGIA  3/84 (3.57%)  5/89 (5.62%)  1/41 (2.44%) 
RECTAL HAEMORRHAGE  3/84 (3.57%)  5/89 (5.62%)  4/41 (9.76%) 
VOMITING  20/84 (23.81%)  22/89 (24.72%)  11/41 (26.83%) 
General disorders       
FATIGUE  7/84 (8.33%)  3/89 (3.37%)  4/41 (9.76%) 
PAIN  5/84 (5.95%)  10/89 (11.24%)  5/41 (12.20%) 
PYREXIA  15/84 (17.86%)  17/89 (19.10%)  9/41 (21.95%) 
Infections and infestations       
URINARY TRACT INFECTION  5/84 (5.95%)  11/89 (12.36%)  1/41 (2.44%) 
WOUND INFECTION  2/84 (2.38%)  5/89 (5.62%)  4/41 (9.76%) 
Injury, poisoning and procedural complications       
ANASTOMOTIC LEAK  9/84 (10.71%)  6/89 (6.74%)  3/41 (7.32%) 
INCISION SITE PAIN  3/84 (3.57%)  3/89 (3.37%)  6/41 (14.63%) 
PROCEDURAL PAINii  19/84 (22.62%)  17/89 (19.10%)  6/41 (14.63%) 
WOUND COMPLICATION  5/84 (5.95%)  2/89 (2.25%)  0/41 (0.00%) 
Investigations       
C-REACTIVE PROTEIN INCREASED  4/84 (4.76%)  6/89 (6.74%)  0/41 (0.00%) 
OXYGEN SATURATION DECREASED  6/84 (7.14%)  1/89 (1.12%)  1/41 (2.44%) 
URINE OUTPUT DECREASED  7/84 (8.33%)  10/89 (11.24%)  2/41 (4.88%) 
WHITE BLOOD CELL COUNT INCREASED  5/84 (5.95%)  2/89 (2.25%)  1/41 (2.44%) 
Metabolism and nutrition disorders       
DECREASED APPETITE  8/84 (9.52%)  6/89 (6.74%)  2/41 (4.88%) 
HYPOKALAEMIA  5/84 (5.95%)  9/89 (10.11%)  5/41 (12.20%) 
Nervous system disorders       
DIZZINESS  5/84 (5.95%)  9/89 (10.11%)  4/41 (9.76%) 
PERIPHERAL SENSORY NEUROPATHY  3/84 (3.57%)  5/89 (5.62%)  2/41 (4.88%) 
Psychiatric disorders       
ANXIETY  5/84 (5.95%)  3/89 (3.37%)  2/41 (4.88%) 
INSOMNIA  7/84 (8.33%)  7/89 (7.87%)  6/41 (14.63%) 
Renal and urinary disorders       
DYSURIA  3/84 (3.57%)  5/89 (5.62%)  2/41 (4.88%) 
URINARY RETENTION  3/84 (3.57%)  5/89 (5.62%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  5/84 (5.95%)  3/89 (3.37%)  1/41 (2.44%) 
PLEURAL EFFUSION  1/84 (1.19%)  5/89 (5.62%)  2/41 (4.88%) 
Skin and subcutaneous tissue disorders       
PRURITUS  9/84 (10.71%)  8/89 (8.99%)  6/41 (14.63%) 
Vascular disorders       
HYPERTENSION  4/84 (4.76%)  9/89 (10.11%)  3/41 (7.32%) 
HYPOTENSION  13/84 (15.48%)  16/89 (17.98%)  5/41 (12.20%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Clinical Development
Organization: Ethicon
Phone: 1 908 218-2492
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01589822     History of Changes
Other Study ID Numbers: 400-11-002
First Submitted: April 30, 2012
First Posted: May 2, 2012
Results First Submitted: July 16, 2014
Results First Posted: February 25, 2015
Last Update Posted: February 25, 2015