Clinical Trial: Ventral Hernia Study Using OviTex Reinforced Bioscaffold

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective, Single Arm, Multi-center Study Evaluating the Short-term Clinical Outcomes of Ventral Hernias Treated With OviTex Reinforced Bioscaffold.

Brief Summary: The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. 100 subjects will be included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair surgery, a baseline visit will be performed during which the patient's eligibility for the study will be evaluated. The surgical technique used for the repair will be determined by the investigator/surgeon. Additional study data will be collected during the hospital stay, 30 and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits, the surgical site will be evaluated by the surgeon, both the surgeon and patient will be asked to rate their satisfaction with the repair and the subject will be asked to complete two Quality of Life questionnaires.

Detailed Summary:

The study is intended to evaluate the post-operative complications and re-herniations following the use of OviTex® Permanent 1S reinforced bioscaffold in subjects with ventral hernias. The study is designed to mirror surgical standard of care for ventral hernia intervention, with the exception of asking for subjects to return for evaluation at longer time points post-surgery than is typical for standard care. A baseline visit will be performed for patients who are identified for and provide informed consent to participate in the study. During this visit, a review of medical history, a physical exam and assessment of the hernia site will be performed. The potential subject will also be asked to complete two quality of life surveys; one that is disease specific and one that is a standard method of health assessment. On the day of surgery, the ventral hernia will be repaired with the use of OviTex® 1S reinforced bioscaffold. Perioperative data will be collected and the surgeon will provide an assessment of the product's handling qualities. During the course of the hospital stay, the subject will be assessed for incidence of early post-operative surgical site wound events and complications, all necessary medical interventions and/or re-operations. On the day of discharge, surgical site occurrences or wound related events noted at the hernia repair site and the occurrence of other post-operative complications will be assessed.

The Day 30 and Day 90 visits will have a visit window of +/- 2 weeks. At these visits, the incidence of late surgical site occurrences or wound related events noted at the hernia repair site will be assessed. If hernia recurrence is suspected, it will be confirmed via diagnostic imaging with a CT scan. The occurrence of other late post-operative complications will also be assessed. The subjects will be asked to complete the same disease specifi
Sponsor: Tela Bio Inc

Current Primary Outcome:

• Incidence of early post-operative surgical site occurrences or wound related events occurring at the hernia repair site. [ Time Frame: within the first three months of the ventral hernia repair ]
  events such as ileus, deep or superficial wound infection, seroma, hematoma, wound dehiscence, skin necrosis, fistula etc..
• Incidence of other early post-operative complications. [ Time Frame: within the first three months of the ventral hernia repair ]
  This would include complications such as ileus, bowel obstruction, fistula etc..

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Incidence of later post-operative surgical site occurrences or wound related events noted at the hernia repair site. [ Time Frame: occurring greater than 3 months after the surgery ]
  This would include events such as ileus, deep or superficial wound infection, serum, hematoma, wound dehiscence, skin necrosis, fistulae, bulging etc..
• Incidence of other later post-operative complications. [ Time Frame: occurring greater than 3 months after the surgery ]
  This would include complications such as ileus, bowel obstruction, fistula etc..
• Patient Reported Outcomes compared to baseline [ Time Frame: Assessed at Day 30, Day 90, Month 12 and Month 24 ]
  Quality of Life and Pain Assessments
• True hernia recurrence at the surgery site [ Time Frame: Assessed at post-operative Day 90 and Months 12 and 24 ]
  Suspected hernia recurrence confirmed via CT scan

Original Secondary Outcome: Same as current

Information By: Tela Bio Inc

Dates:
Date Received: March 3, 2017
Date Started: March 2017
Date Completion: November 2020
Last Updated: March 3, 2017
Last Verified: March 2017