The Study Comparing the Efficacy, Safety, and Cost of a Permanent, Synthetic Prosthetic Versus a Biologic Prosthetic in the One-Stage Repair of Ventral Hernias in Clean and Contaminated Wounds is an interventional trial currently recruiting patients with ventral hernias.
The trial will compare results of ventral hernia repair in patients who have received a biologic mesh made from pig skin with those who received a synthetic mesh made in a laboratory. Both study groups will include patients with and without infection near the hernia. Synthetic mesh is hypothesized to have a higher rate of early postoperative infection, while biologic mesh is hypothesized to have a higher rate of recurrence.
Patients will be included in the trial if they have a ventral hernia; are older than 21 years; are not pregnant; and have no allergic, religious, or ethical objections to polypropylene or porcine prosthetics. Reasons for exclusion include severe malnutrition, pre-existing parenchymal liver disease, immunocompromisation, and refractory ascites.
The primary outcome measure is recurrence within 24 months of surgery, and the secondary outcome measure is wound events within 24 months of surgery. Other outcome measures include early postoperative complications within 1 month of surgery and quality of life, pain, activity level, and overall cost with 24 months of surgery.
The study will end in June 2019. About 330 people are expected to be included in the final analysis.
Find more information at the study page on Clinicaltrials.gov.