SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Prospective, multi center, single arm, clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.

Detailed Description
-----------------
Prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Subjects will be followed for 24 months post SERI placement during index hernia repair surgery. Study visits will occur at screening, from SERI implantation through hospital discharge and then post SERI implantation at month(s) 1, 3, 6, 12, 18, and 24 for all enrolled subjects.

Official Title
-----------------
A SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair

Conditions
-----------------
Ventral Hernia Repair

Intervention / Treatment
-----------------
* Device: Silk surgical mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The following are requirements for entry into the study. The subject MUST: 1. Be ≥ 18 years of age 2. Be diagnosed with a ventral hernia as defined as: Midline Ventral Hernia AND Defect(s) MUST meet the following criteria: contained within an anatomical area of ≤ 150 cm2 not be longer than 8cm in any direction size must have a total sum ≤ 64 cm2 Be eligible for retro-rectus placement of SERI Have a BMI < 40 Exclusion Criteria: The following are criteria for exclusion from participating in the study. The subject must NOT: Be > 70 years of age Have prior occurrence of ventral hernia or parastomal hernia Have a presence of a stoma or have a perforated bowel Have any documented disease which is clinically known to impact wound healing, including Chronic Obstructive Pulmonary Disease (COPD), and Congestive Heart Failure (CHF), with the exception of controlled diabetes Have documented history of diabetes with an A1C of ≥ 8 at time of pre-operative visit Have documented autoimmune disease, an immune deficiency, or be on immunosuppressive drugs with the exception of steroids for: 1. prophylactic one-time-use administered peri-operatively 2. inhaled general use 3. topical administration 7. Have documented collagen-vascular, connective tissue, bleeding disorders and/or on anticoagulation therapy, with the exception of baby aspirin for one week prior to SERI placement 8. Have documented cancer < 6 months prior to surgery or chemotherapy treatment < 6 months prior to surgery 9. Have documented history of abdominal radiation therapy or is expected to have abdominal radiation therapy during the conduct of this study 10. Have documented history of liver disease and/or renal failure requiring dialysis 11. Have documented history of a previous wound infection at the surgical site or have an active infection at the time of surgery 12. Have had prior surgery with synthetic and/or biologic mesh in the abdominal, chest or pelvic area 13. Have documented allergy to silk 14. Have documented UTI at the time of surgery 15. Have smoked within 6 weeks of surgery and have a positive nicotine test at time of preoperative visit 16. Have a concurrent procedure intra-operatively (with the exception of lysis of abdominal adhesions) 17. Require intra-peritoneal or bridging placement of the soft tissue support device or require component separation at time of surgery 18. Have surgical circumstances that are contraindicated for use of SERI™ Surgical Scaffold per the supplied package insert 19. Have a concomitant unrelated condition of abdominal/chest wall/skin that would require a surgical intervention during the follow-up period 20. Have documented alcohol and/or substance abuse problem at time of pre-operative visit 21. Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SERI® Surgical Scaffold<br>It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. | Device: Silk surgical mesh<br>* A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair<br>* Other names: SERI® Surgical Scaffold;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Hernia Recurrence | Hernia recurrence at 6 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician. | 6 months postoperatively | 
| Rate of Hernia Recurrence | Hernia recurrence at 12 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician. | 12 months postoperatively | 
| Rate of Hernia Recurrence | Hernia recurrence at 24 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician. | 24 months postoperatively |