Prospective, Multicenter, Observational Study To Evaluate Single-Staged Open Complex Ventral Incisional Hernia Repair Using a Bioabsorbable Material For Midline Fascial Closure Reinforcement (GORE® BIO-A® Tissue Reinforcement)
ID Number 11-0053Principal Investigator(s)
Joel J Bauer
Department(s) or Division(s)
The purpose of this study is to examine both the benefits and risks of using a bioabsorbable material to reinforce weakened tissue in the abdominal wall during and after ventral incisional hernia repair surgery. This study will specifically look at how successful an FDA-approved bioabsorbable material (GORE ® BIO-A® Tissue Reinforcement) is at repairing ventral incisional hernias. A ventral incisional hernia is the tearing apart or rupture of smooth muscle through which a part of the body protrudes at an old incision site in the abdomen. The bioabsorbable material is used to reconstruct abdominal wall tissue at the site of the hernia defect where the tissue is weakened and it will provide some support during wound healing. The study will evaluate how the material affects early and long-term recovery including post-operative quality of life, rate of hernia recurrence or any other complications. Patients who qualify to take part in this research study have been diagnosed with a ventral incisional hernia and will have been scheduled for a surgical hernia repair. This surgery would be an “open” (as opposed to laparoscopic) surgical procedure and reinforcing the patient’s tissue with material is indicated for this type of hernia repair. This study is currently closed to enrollment and conducting only follow-up visits.
Recruiting Patients: No