A SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair
This trial is active, not recruiting.
|Condition||ventral hernia repair|
|Treatment||silk surgical mesh|
|Start date||October 2013|
|End date||December 2016|
|Trial size||1 participant|
|Trial identifier||NCT01981044, SURE-007|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Rate of hernia recurrence
time frame: 24 months postoperatively
Male or female participants from 18 years up to 70 years old.
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: 1. Midline Ventral Hernia AND 2. 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 3. Be eligible for retro-rectus placement of SERI 4. Have a BMI < 40 Exclusion Criteria: The following are criteria for exclusion from participating in the study. The subject must NOT: 1. Be > 70 years of age 2. Have prior occurrence of ventral hernia or parastomal hernia 3. Have a presence of a stoma or have a perforated bowel 4. 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 5. Have documented history of diabetes with an A1C of ≥ 8 at time of pre-operative visit 6. 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
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