Trial Outcomes & Findings for Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias (NCT NCT02451176)
NCT ID: NCT02451176
Last Updated: 2022-09-07
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
253 participants
Primary outcome timeframe
2 years from surgery
Results posted on
2022-09-07
Participant Flow
Participant milestones
| Measure |
Active Comparator: Davol Bard ®Soft Mesh
Device: Davol Bard ®Soft Mesh Synthetic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: synthetic mesh SoftMesh™ (CR Bard)
Davol Bard Soft Mesh synthetic: soft mesh synthetic
|
Active Comparator: LifeCell Strattice®
Device: LifeCell Strattice® Reconstructive Tissue Matrix Biologic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: Biologic mesh Strattice
LifeCell Strattice Reconstructive Tissue Biologic: biologic mesh
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
127
|
|
Overall Study
COMPLETED
|
126
|
127
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias
Baseline characteristics by cohort
| Measure |
Active Comparator: Davol Bard ®Soft Mesh
n=126 Participants
Device: Davol Bard ®Soft Mesh Synthetic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: synthetic mesh SoftMesh™ (CR Bard)
Davol Bard Soft Mesh synthetic: soft mesh synthetic
|
Active Comparator: LifeCell Strattice®
n=127 Participants
Device: LifeCell Strattice® Reconstructive Tissue Matrix Biologic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: Biologic mesh Strattice
LifeCell Strattice Reconstructive Tissue Biologic: biologic mesh
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 Years
n=5 Participants
|
63.7 Years
n=7 Participants
|
63.7 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian not Hispanic
|
116 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 years from surgeryOutcome measures
| Measure |
Active Comparator: Davol Bard ®Soft Mesh
n=126 Participants
Device: Davol Bard ®Soft Mesh Synthetic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: synthetic mesh SoftMesh™ (CR Bard)
Davol Bard Soft Mesh synthetic: soft mesh synthetic
|
Active Comparator: LifeCell Strattice®
n=127 Participants
Device: LifeCell Strattice® Reconstructive Tissue Matrix Biologic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: Biologic mesh Strattice
LifeCell Strattice Reconstructive Tissue Biologic: biologic mesh
|
|---|---|---|
|
Number of Participants With Absence of Surgical Site Occurrence Requiring Procedural Intervention
No surgical site occurrence requiring procedural intervention
|
124 Participants
|
126 Participants
|
|
Number of Participants With Absence of Surgical Site Occurrence Requiring Procedural Intervention
Presence of surgical site occurrence requiring procedural intervention
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 2 years post surgeryOutcome measures
| Measure |
Active Comparator: Davol Bard ®Soft Mesh
n=115 Participants
Device: Davol Bard ®Soft Mesh Synthetic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: synthetic mesh SoftMesh™ (CR Bard)
Davol Bard Soft Mesh synthetic: soft mesh synthetic
|
Active Comparator: LifeCell Strattice®
n=118 Participants
Device: LifeCell Strattice® Reconstructive Tissue Matrix Biologic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: Biologic mesh Strattice
LifeCell Strattice Reconstructive Tissue Biologic: biologic mesh
|
|---|---|---|
|
Total Number of Participants With Recurrence of Hernias
|
7 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 30 days post surgeryCalculate and compare incremental cost effectiveness ratios for patients undergoing repair of clean-contaminated or contaminated ventral hernias using either polypropylene mesh or biologic mesh
Outcome measures
| Measure |
Active Comparator: Davol Bard ®Soft Mesh
n=105 Participants
Device: Davol Bard ®Soft Mesh Synthetic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: synthetic mesh SoftMesh™ (CR Bard)
Davol Bard Soft Mesh synthetic: soft mesh synthetic
|
Active Comparator: LifeCell Strattice®
n=103 Participants
Device: LifeCell Strattice® Reconstructive Tissue Matrix Biologic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: Biologic mesh Strattice
LifeCell Strattice Reconstructive Tissue Biologic: biologic mesh
|
|---|---|---|
|
Direct Costs Associated With the Use of Either Polypropylene or Biologic Mesh
Direct cost Surgical Admission
|
17110 US Dollars
Interval 14044.0 to 22677.0
|
44530 US Dollars
Interval 35172.0 to 52496.0
|
|
Direct Costs Associated With the Use of Either Polypropylene or Biologic Mesh
Total 30 day direct cost
|
17289 US Dollars
Interval 14643.0 to 23901.0
|
44936 US Dollars
Interval 35887.0 to 54656.0
|
Adverse Events
Active Comparator: Davol Bard ®Soft Mesh
Serious events: 11 serious events
Other events: 108 other events
Deaths: 5 deaths
Active Comparator: LifeCell Strattice®
Serious events: 11 serious events
Other events: 103 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Active Comparator: Davol Bard ®Soft Mesh
n=126 participants at risk
Device: Davol Bard ®Soft Mesh Synthetic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: synthetic mesh SoftMesh™ (CR Bard)
Davol Bard Soft Mesh synthetic: soft mesh synthetic
|
Active Comparator: LifeCell Strattice®
n=127 participants at risk
Device: LifeCell Strattice® Reconstructive Tissue Matrix Biologic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: Biologic mesh Strattice
LifeCell Strattice Reconstructive Tissue Biologic: biologic mesh
|
|---|---|---|
|
Infections and infestations
Surgical Site Infection
|
3.2%
4/126 • Number of events 4 • 2 years post surgery
|
2.4%
3/127 • Number of events 3 • 2 years post surgery
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/126 • 2 years post surgery
|
1.6%
2/127 • Number of events 2 • 2 years post surgery
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Injury, poisoning and procedural complications
Non-Healing wound
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Blood and lymphatic system disorders
Bleeding
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
General disorders
Abdominal Pain
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Surgical and medical procedures
Foreign Body Removal
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Product Issues
Obstruction of Transplant Ureter
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Surgical and medical procedures
Mesh Repair
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Gastrointestinal disorders
Bowel Perforation
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
General disorders
Seroma
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Surgical and medical procedures
nsertion of Peripheral Central Venous Access Device
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Infections and infestations
Urinary Tract Infection
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
Other adverse events
| Measure |
Active Comparator: Davol Bard ®Soft Mesh
n=126 participants at risk
Device: Davol Bard ®Soft Mesh Synthetic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: synthetic mesh SoftMesh™ (CR Bard)
Davol Bard Soft Mesh synthetic: soft mesh synthetic
|
Active Comparator: LifeCell Strattice®
n=127 participants at risk
Device: LifeCell Strattice® Reconstructive Tissue Matrix Biologic mesh for open ventral hernia repair for clean-contaminated or contaminated abdominal wall hernias Other Name: Biologic mesh Strattice
LifeCell Strattice Reconstructive Tissue Biologic: biologic mesh
|
|---|---|---|
|
Infections and infestations
Surgical Site Infection
|
7.1%
9/126 • Number of events 9 • 2 years post surgery
|
13.4%
17/127 • Number of events 17 • 2 years post surgery
|
|
Gastrointestinal disorders
Esophageal Stricture
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 10 • 2 years post surgery
|
|
Gastrointestinal disorders
Esophageal Ulceration
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 10 • 2 years post surgery
|
|
Gastrointestinal disorders
Ileus
|
16.7%
21/126 • Number of events 21 • 2 years post surgery
|
14.2%
18/127 • Number of events 18 • 2 years post surgery
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
4/126 • Number of events 4 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Infections and infestations
Cellulitis
|
2.4%
3/126 • Number of events 3 • 2 years post surgery
|
4.7%
6/127 • Number of events 6 • 2 years post surgery
|
|
Infections and infestations
Pouchitis
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Blood and lymphatic system disorders
Hematoma
|
2.4%
3/126 • Number of events 3 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Infections and infestations
Wound Infection
|
2.4%
3/126 • Number of events 3 • 2 years post surgery
|
1.6%
2/127 • Number of events 2 • 2 years post surgery
|
|
Blood and lymphatic system disorders
Anemia
|
4.0%
5/126 • Number of events 5 • 2 years post surgery
|
4.7%
6/127 • Number of events 6 • 2 years post surgery
|
|
Gastrointestinal disorders
Bowel Obstruction
|
7.1%
9/126 • Number of events 9 • 2 years post surgery
|
2.4%
3/127 • Number of events 3 • 2 years post surgery
|
|
General disorders
Seroma
|
3.2%
4/126 • Number of events 4 • 2 years post surgery
|
3.1%
4/127 • Number of events 4 • 2 years post surgery
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/126 • 2 years post surgery
|
2.4%
3/127 • Number of events 3 • 2 years post surgery
|
|
Renal and urinary disorders
Urinary Tract Infection
|
5.6%
7/126 • Number of events 7 • 2 years post surgery
|
9.4%
12/127 • Number of events 12 • 2 years post surgery
|
|
Infections and infestations
C-Diff
|
2.4%
3/126 • Number of events 3 • 2 years post surgery
|
1.6%
2/127 • Number of events 2 • 2 years post surgery
|
|
Infections and infestations
Suture Abscess
|
2.4%
3/126 • Number of events 3 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Skin and subcutaneous tissue disorders
Incisional Erythema
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Psychiatric disorders
Delirium
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Vascular disorders
Pulmonary Embolism
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/126 • 2 years post surgery
|
1.6%
2/127 • Number of events 2 • 2 years post surgery
|
|
Infections and infestations
Organ Space Infection
|
1.6%
2/126 • Number of events 2 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Injury, poisoning and procedural complications
Non-Healing Wound
|
1.6%
2/126 • Number of events 2 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Infections and infestations
Pneumonia
|
2.4%
3/126 • Number of events 3 • 2 years post surgery
|
1.6%
2/127 • Number of events 2 • 2 years post surgery
|
|
General disorders
Dehydration
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.4%
3/126 • Number of events 3 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Cardiac disorders
Atrial Fibrillation
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
3.1%
4/127 • Number of events 4 • 2 years post surgery
|
|
General disorders
Abdominal Pain
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Infections and infestations
PICC line infection
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Renal and urinary disorders
Urine Leak
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Gastrointestinal disorders
Nausea
|
2.4%
3/126 • Number of events 3 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
4/126 • Number of events 4 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Gastrointestinal disorders
Constipation
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
General disorders
Fever
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Surgical and medical procedures
Scar Revision
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Injury, poisoning and procedural complications
Drainage for JP removal site
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Infections and infestations
Abscess
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Infections and infestations
Sepsis
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Cardiac disorders
Hypotension
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Vascular disorders
Abdominal Aortic Aneurysm
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Eye disorders
Torn Retina
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
General disorders
Chest Pain
|
0.00%
0/126 • 2 years post surgery
|
0.79%
1/127 • Number of events 1 • 2 years post surgery
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Upper Lip Hemangioma
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Gastrointestinal disorders
Fistula
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Surgical and medical procedures
Small Bowel Enterotomy
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Cardiac disorders
Cardiac Arrest
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
|
Vascular disorders
Stroke
|
0.79%
1/126 • Number of events 1 • 2 years post surgery
|
0.00%
0/127 • 2 years post surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place