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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 1

Inclusion Criteria

The following are requirements for entry into the study. The subject MUST:

Be ≥ 18 years of age
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:
prophylactic one-time-use administered peri-operatively
inhaled general use
topical administration
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
Have documented cancer < 6 months prior to surgery or chemotherapy treatment < 6 months prior to surgery
Have documented history of abdominal radiation therapy or is expected to have abdominal radiation therapy during the conduct of this study
Have documented history of liver disease and/or renal failure requiring dialysis
Have documented history of a previous wound infection at the surgical site or have an active infection at the time of surgery
Have had prior surgery with synthetic and/or biologic mesh in the abdominal, chest or pelvic area
Have documented allergy to silk
Have documented UTI at the time of surgery
Have smoked within 6 weeks of surgery and have a positive nicotine test at time of preoperative visit
Have a concurrent procedure intra-operatively (with the exception of lysis of abdominal adhesions)
Require intra-peritoneal or bridging placement of the soft tissue support device or require component separation at time of surgery
Have surgical circumstances that are contraindicated for use of SERI™ Surgical Scaffold per the supplied package insert
Have a concomitant unrelated condition of abdominal/chest wall/skin that would require a surgical intervention during the follow-up period
Have documented alcohol and/or substance abuse problem at time of pre-operative visit
Be pregnant, lactating, or if of childbearing potential, be unwilling to use contraceptive methods and avoid pregnancy throughout the study

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SERI® Surgical Scaffold	Silk surgical mesh	It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device.

Primary Outcome Measures

Name	Time	Method
Rate of Hernia Recurrence	24 months postoperatively	Hernia recurrence at 24 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.

Secondary Outcome Measures