This trial is active, not recruiting.

Condition ventral hernia repair
Treatment silk surgical mesh
Sponsor Allergan
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
It is a prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device.
silk surgical mesh SERI® Surgical Scaffold
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

Primary Outcomes

Rate of hernia recurrence
time frame: 24 months postoperatively

Eligibility Criteria

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

Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Allergan.