At a glance
ClinicalIndex Comparison Record- ✓Age > 18 years
- ✓Elective hernia repair with VHWG grade 2 or above (hernia causing symptoms, functional impairment, or incarceration risk) with comorbidities or contamination making synthetic mesh contraindicated
- ✓Good surgical candidate without active life-threatening cardiac, pulmonary, renal, or hematologic disease
- ✓Presenting for resection of large abdominal wall tumors requiring biologic mesh for closure of resulting defect
- ✕Known allergy to porcine products
- ✕Active smoker within past 4 weeks (for elective hernia repair)
- ✕Active life-threatening cardiac, pulmonary, renal, or hematologic disease (for elective hernia repair)
- ✕Emergent hernia repair (bowel strangulation, necrosis, penetrating trauma)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction
In Brief
A clinical study evaluating Abdominal wall reconstruction with Strattice, Assess pain intensity at last office visit preoperatively, and 18 other interventions for Hernia, Ventral and 2 related conditions. Completed, enrolled 46 participants across 1 site.
Detailed Summary
The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.
Study Details
Timeline
Interventions
Abdominal wall reconstruction using Strattice
Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
Assess quality of life at 1 year postoperatively using the HerQLes survey
Assess hernia recurrence at 30 days
Assess bulge at 30 days
Assess Surgical Site Occurrences at 30 days
Assess hernia recurrence at 1 year postoperatively
Assess bulge at 1 year postoperatively
Assess Surgical Site Occurrences at 1 year postoperatively
Abdominal wall reconstruction with XenMatrix
Strattice mesh
Xenmatrix mesh