Trial Outcomes & Findings for A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair (NCT NCT02587403)
NCT ID: NCT02587403
Last Updated: 2024-12-27
Results Overview
True hernia recurrence as diagnosed by physical exam or CT scan
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
12 months
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Fortiva™ Porcine Dermis
Fortiva™ Porcine Dermis: Fortiva Porcine Dermis implantation during repair of complex ventral hernia
|
Strattice™ Reconstructive Tissue Matrix
Strattice™ Reconstructive Tissue Matrix: Strattice tissue matrix implanted during repair of complex ventral hernia
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
51
|
44
|
|
Overall Study
NOT COMPLETED
|
9
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Fortiva and Strattice Tissue Matrices in Complex, Ventral Hernia Repair
Baseline characteristics by cohort
| Measure |
Fortiva™ Porcine Dermis
n=60 Participants
Fortiva™ Porcine Dermis: Fortiva Porcine Dermis implantation during repair of complex ventral hernia
|
Strattice™ Reconstructive Tissue Matrix
n=60 Participants
Strattice™ Reconstructive Tissue Matrix: Strattice tissue matrix implanted during repair of complex ventral hernia
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 10.5 • n=99 Participants
|
59.2 years
STANDARD_DEVIATION 13.1 • n=107 Participants
|
59.4 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
60 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
Body Mass Index
|
31.7 kg/m^2
STANDARD_DEVIATION 4.7 • n=99 Participants
|
32.3 kg/m^2
STANDARD_DEVIATION 5.4 • n=107 Participants
|
32 kg/m^2
STANDARD_DEVIATION 5.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsTrue hernia recurrence as diagnosed by physical exam or CT scan
Outcome measures
| Measure |
Fortiva™ Porcine Dermis
n=60 Participants
Fortiva™ Porcine Dermis: Fortiva Porcine Dermis implantation during repair of complex ventral hernia
|
Strattice™ Reconstructive Tissue Matrix
n=60 Participants
Strattice™ Reconstructive Tissue Matrix: Strattice tissue matrix implanted during repair of complex ventral hernia
|
|---|---|---|
|
The Proportion of Patients Who Experience a True Hernia Recurrence
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 monthsSF-36 mental component summary scale ranges from 0-100. Higher score indicates better self reported health.
Outcome measures
| Measure |
Fortiva™ Porcine Dermis
n=54 Participants
Fortiva™ Porcine Dermis: Fortiva Porcine Dermis implantation during repair of complex ventral hernia
|
Strattice™ Reconstructive Tissue Matrix
n=49 Participants
Strattice™ Reconstructive Tissue Matrix: Strattice tissue matrix implanted during repair of complex ventral hernia
|
|---|---|---|
|
SF-36 MCS
|
48.9 score on a scale
Standard Deviation 9.2
|
48.9 score on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: 3 monthsVisual analog scale measures extremes of pain on a scale from 0-10. 0 is no pain and 10 is worst pain
Outcome measures
| Measure |
Fortiva™ Porcine Dermis
n=54 Participants
Fortiva™ Porcine Dermis: Fortiva Porcine Dermis implantation during repair of complex ventral hernia
|
Strattice™ Reconstructive Tissue Matrix
n=49 Participants
Strattice™ Reconstructive Tissue Matrix: Strattice tissue matrix implanted during repair of complex ventral hernia
|
|---|---|---|
|
Pain Measured Using the Visual Analog Scale for Pain
|
2.41 units on a scale
Standard Deviation 2.22
|
2.37 units on a scale
Standard Deviation 2.32
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Fortiva™ Porcine Dermis
n=55 Participants
Fortiva™ Porcine Dermis: Fortiva Porcine Dermis implantation during repair of complex ventral hernia
|
Strattice™ Reconstructive Tissue Matrix
n=52 Participants
Strattice™ Reconstructive Tissue Matrix: Strattice tissue matrix implanted during repair of complex ventral hernia
|
|---|---|---|
|
True Recurrence at 24 Months
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: DischargeTime is from date of procedure to date of each patient discharge. Mean of each group is provided
Outcome measures
| Measure |
Fortiva™ Porcine Dermis
n=55 Participants
Fortiva™ Porcine Dermis: Fortiva Porcine Dermis implantation during repair of complex ventral hernia
|
Strattice™ Reconstructive Tissue Matrix
n=53 Participants
Strattice™ Reconstructive Tissue Matrix: Strattice tissue matrix implanted during repair of complex ventral hernia
|
|---|---|---|
|
Time to Discharge
|
7.93 Days
Standard Deviation 2.32
|
8.11 Days
Standard Deviation 3.39
|
Adverse Events
Fortiva™ Porcine Dermis
Serious events: 13 serious events
Other events: 25 other events
Deaths: 0 deaths
Strattice™ Reconstructive Tissue Matrix
Serious events: 23 serious events
Other events: 23 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Fortiva™ Porcine Dermis
n=60 participants at risk
Fortiva™ Porcine Dermis: Fortiva Porcine Dermis implantation during repair of complex ventral hernia
|
Strattice™ Reconstructive Tissue Matrix
n=60 participants at risk
Strattice™ Reconstructive Tissue Matrix: Strattice tissue matrix implanted during repair of complex ventral hernia
|
|---|---|---|
|
Infections and infestations
Seroma
|
5.0%
3/60 • 2 years
Site reported adverse events
|
0.00%
0/60 • 2 years
Site reported adverse events
|
|
Infections and infestations
Abdominal Wall Infection
|
1.7%
1/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Cardiac disorders
Atrial fibrillation with RVR
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
General disorders
Abdominal Pain
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Endocrine disorders
Acute Kidney Injury
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Insufficiency
|
1.7%
1/60 • 2 years
Site reported adverse events
|
0.00%
0/60 • 2 years
Site reported adverse events
|
|
Gastrointestinal disorders
CHOLECOCHOLITHIASIS
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
General disorders
Dehydration
|
0.00%
0/60 • 2 years
Site reported adverse events
|
3.3%
2/60 • 2 years
Site reported adverse events
|
|
Gastrointestinal disorders
Diverticulitis
|
1.7%
1/60 • 2 years
Site reported adverse events
|
0.00%
0/60 • 2 years
Site reported adverse events
|
|
General disorders
Dizziness
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/60 • 2 years
Site reported adverse events
|
3.3%
2/60 • 2 years
Site reported adverse events
|
|
Cardiac disorders
Endocarditis
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
Fluid Collection
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
Fluid Overload
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Gastrointestinal disorders
GI Bleed
|
1.7%
1/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
General disorders
Headache
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
Hematoma
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
General disorders
Hyponatremia
|
1.7%
1/60 • 2 years
Site reported adverse events
|
0.00%
0/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
Intra abdominal abscess
|
0.00%
0/60 • 2 years
Site reported adverse events
|
5.0%
3/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
Intra abdominal fluid collection
|
1.7%
1/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
General disorders
Multisystem organ failure
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
Pain
|
1.7%
1/60 • 2 years
Site reported adverse events
|
0.00%
0/60 • 2 years
Site reported adverse events
|
|
Gastrointestinal disorders
Partial small bowel obstruction
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
PICC line infection
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Cardiac disorders
Progressive Atherosclerotic
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
General disorders
Pulmonary embolism
|
1.7%
1/60 • 2 years
Site reported adverse events
|
0.00%
0/60 • 2 years
Site reported adverse events
|
|
Gastrointestinal disorders
Recurrent GI bleed
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Infections and infestations
Sepsis
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Gastrointestinal disorders
Small bowel obstruction
|
3.3%
2/60 • 2 years
Site reported adverse events
|
6.7%
4/60 • 2 years
Site reported adverse events
|
|
General disorders
Subcarinal mass with metastis to brain
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Cardiac disorders
Symptomatic bradycardia
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Cardiac disorders
Third degree AV block
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Cardiac disorders
Valve infection
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
|
Infections and infestations
Wound infection
|
0.00%
0/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
Other adverse events
| Measure |
Fortiva™ Porcine Dermis
n=60 participants at risk
Fortiva™ Porcine Dermis: Fortiva Porcine Dermis implantation during repair of complex ventral hernia
|
Strattice™ Reconstructive Tissue Matrix
n=60 participants at risk
Strattice™ Reconstructive Tissue Matrix: Strattice tissue matrix implanted during repair of complex ventral hernia
|
|---|---|---|
|
Infections and infestations
Abdominal cellulitis
|
1.7%
1/60 • 2 years
Site reported adverse events
|
6.7%
4/60 • 2 years
Site reported adverse events
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
2/60 • 2 years
Site reported adverse events
|
0.00%
0/60 • 2 years
Site reported adverse events
|
|
Infections and infestations
Cellulitis
|
1.7%
1/60 • 2 years
Site reported adverse events
|
3.3%
2/60 • 2 years
Site reported adverse events
|
|
General disorders
Constipation
|
3.3%
2/60 • 2 years
Site reported adverse events
|
3.3%
2/60 • 2 years
Site reported adverse events
|
|
General disorders
Hallucinations
|
3.3%
2/60 • 2 years
Site reported adverse events
|
0.00%
0/60 • 2 years
Site reported adverse events
|
|
General disorders
Hypocalcemia
|
3.3%
2/60 • 2 years
Site reported adverse events
|
0.00%
0/60 • 2 years
Site reported adverse events
|
|
General disorders
Hyphosphatemia
|
3.3%
2/60 • 2 years
Site reported adverse events
|
3.3%
2/60 • 2 years
Site reported adverse events
|
|
General disorders
Itching
|
0.00%
0/60 • 2 years
Site reported adverse events
|
3.3%
2/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
Nausea
|
5.0%
3/60 • 2 years
Site reported adverse events
|
3.3%
2/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
Open wound
|
5.0%
3/60 • 2 years
Site reported adverse events
|
0.00%
0/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
Post op pain
|
10.0%
6/60 • 2 years
Site reported adverse events
|
3.3%
2/60 • 2 years
Site reported adverse events
|
|
General disorders
Seroma
|
10.0%
6/60 • 2 years
Site reported adverse events
|
18.3%
11/60 • 2 years
Site reported adverse events
|
|
Renal and urinary disorders
Urinary tract infection
|
3.3%
2/60 • 2 years
Site reported adverse events
|
0.00%
0/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
6.7%
4/60 • 2 years
Site reported adverse events
|
5.0%
3/60 • 2 years
Site reported adverse events
|
|
Injury, poisoning and procedural complications
Wound infection
|
5.0%
3/60 • 2 years
Site reported adverse events
|
1.7%
1/60 • 2 years
Site reported adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place