N/A
N=253
Biologic Mesh Versus Synthetic Mesh in Repair of Ventral Hernias
Ventral Hernia
Bottom Line
View on ClinicalTrials.gov: NCT02451176 ↗Enrolled (actual)
253
Serious AEs
8.7%
Results posted
Sep 2022
Primary outcome: Primary: Number of Participants With Absence of Surgical Site Occurrence Requiring Procedural Intervention — 124; 126; 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Davol Bard Soft Mesh synthetic (Device); LifeCell Strattice Reconstructive Tissue Biologic (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Michael Rosen
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Absence of Surgical Site Occurrence Requiring Procedural Intervention |
124; 126; 2; 1 | — |
| PRIMARY Total Number of Participants With Recurrence of Hernias |
7; 24 | — |
| SECONDARY Direct Costs Associated With the Use of Either Polypropylene or Biologic Mesh |
17110; 44530; 17289; 44936 | — |
Summary
This study will compare the safety, efficacy and cost effectiveness of a permanent synthetic mesh versus a biologic prosthesis for the repair of ventral hernias in the setting of clean-contaminated (Class 2) or contaminated (Class 3) surgical procedures. The findings of this study will have a major impact on the field of hernia surgery as it will provide objective guide to mesh selection, optimize surgical approaches for complex ventral hernia repair, and ultimately significantly improve patient outcomes.
Eligibility Criteria
Inclusion Criteria
- The subject is > 21 years of age (including women of childbearing age)
- Scheduled to undergo a planned open single stage reconstruction of a contaminated (CDC wound class2 or 3) abdominal wall defect
- Ability to undergo general anesthesia
- Is willing and able to give informed consent
- Is this a clean-contaminated (Class 2) or contaminated (Class 3) case per CDC Guidelines?
- Has an estimated parastomal hernia or midline defect size of >9 cm 2 contaminated (CDC wound class 2 or 3) abdominal wall defect by physical /or radiological exam.
- Can achieve midline fascial closure?
- Is subject willing to return for scheduled and required study visits? -
Exclusion Criteria
- Patients have a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh.
- Is the patients BMI over 45 kg/m2?
- Is the patient currently pregnant?
- Will undergo a laparoscopic or robotic hernia repair.
- Do they have a class 1 or 4 wound per CDC Guidelines?
- Are they on immunosuppression including medically-induced with>10 mg of prednisone/day?
- Do they have a collagen vascular disorder?
- Is patient having a prior mesh removed due to a current active mesh infection? (A synthetic mesh that is not incorporated into the tissue, is extracorporeally exposed or has a chronic draining sinus with clear fluid around the material, but not including synthetic mesh incorporated in abdominal wall and not infected)
- Does the patient have Ascites refractory to medical management?
- Are they in end stage renal (on hemodialysis or peritoneal dialysis) or pre-existing liver disease (Hepatitis B or C or Total Bilirubin >3.0mg/dl)?
- Is the patient severely malnourished as defined by serum albumin<2.0g/dl?
- Do they have a smoking history within 1 month of surgery?
- Does the patient have an objection to the implantation of porcine products?
- Is the subject participating in another clinical study?
- Are unable to undergo successful retro-rectus/preperitoneal mesh placement
Data sourced from ClinicalTrials.gov (NCT02451176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.