A Randomized, Prospective Study Comparing Fortiva™ Porcine Dermis vs. Strattice™ Reconstructive Tissue Matrix in Patients Undergoing Complex Open Primary Ventral Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RTI Surgical
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The Proportion of Patients Who Experience a True Hernia Recurrence
研究概览
简要总结
The objective of this study is to compare the effectiveness of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix for the underlay reinforcement of complex ventral hernia repair and assess post-operative complication rates, long term hernia recurrence rates.
详细描述
This is a randomized, prospective, double-blinded study evaluating the efficacy of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix in 120 patients with large complex abdominal wall ventral hernias undergoing single stage repair. The patient will be blinded to treatment as well as an independent qualified evaluator to confirm evidence of reoccurrence. This post-market study compares two FDA cleared biologic hernia materials. Fortiva™ porcine dermis, processed by RTI Surgical, Inc., a non-cross linked porcine dermis will be compared to Strattice™ Reconstructive Tissue Matrix by Life Cell, a non-cross linked porcine dermis for reinforcement during the single stage open reconstruction of abdominal wall defects. The primary outcome will be hernia recurrence at 1 year. Outcomes will be evaluated at 6 weeks, 3 months, 6 months and 12 months and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or greater
- •Have a BMI < or equal to 40
- •Have a pre-operative estimated hernia defect of 200 cm2 OR multiple hernia defects whose combined area is ≥ an estimated 200 cm
- •Patients whose defects do NOT meet or exceed 200 cm2 intra-operatively will be withdrawn from the study and will be considered an intra-operative screen failure
- •Have no contraindications to the test material (s)
- •Have a life expectancy greater than 1 year in the opinion of the Investigator
- •Able to provide informed consent
- •Able and willing to return for scheduled study visits over 2 years post-operatively (following research related surgery)
排除标准
- •< 18 years of age
- •Subject is determined to have an American Society of Anesthesiologists'(ASA) physical class of 4, 5, or 6
- •Have a BMI >40
- •Have a hernia estimated to be <200 cm2
- •Have abdominal loss of domain such that the operation would be impractical or would adversely affect respiratory or cardiovascular function to an unacceptable degree in the opinion of the investigator
- •Inability to close the fascia primarily without abdominal wall mobilization or component separation
- •Participation in an investigational drug or device study that would impact the safety or scientific integrity of this study (in the opinion of the Investigator and with the approval of the Sponsor) within the past 6 weeks prior to enrollment into this trial
- •Have active necrotizing fasciitis or any other known active local or systemic infection
- •Have a known collagen metabolism disorder or any medical condition that could interfere with normal tissue healing process as determined by the Investigator
- •Have a known active malignancy present and/or had chemotherapy 12 weeks prior to screening or planned chemotherapy within 12 weeks of enrollment with exception of BCC or SCC
- •Have known moderate to severe cirrhosis which in the opinion of the Investigator would impact the outcome of this trial
- •Have a life expectancy less than 1 year
- •Be unable to participate in the informed consent process
- •Be unable or unwilling to return for scheduled study visits over the 2 year post-operative assessment period
- •Received high dose steroids (>/=100mg of prednisone) within the past 6 weeks
- •Known tobacco use within the past 6 weeks or positive serum cotinine test at time of admission
- •Uncontrolled diabetes (i.e. known HbA1C value > 7% within the last 6 weeks)
- •History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up
- •Pregnancy and/or breastfeeding
- •Enterocutaneous fistula
- •Ventral hernia repairs involving active infection
- •Inability to obtain primary fascial closure (Intra-operatively)
- •Planned use of external VAC dressing intra-operatively
结局指标
主要结局
The Proportion of Patients Who Experience a True Hernia Recurrence
时间窗: 12 months
True hernia recurrence as diagnosed by physical exam or CT scan
次要结局
- SF-36 MCS(3 months)
- Pain Measured Using the Visual Analog Scale for Pain(3 months)
- True Recurrence at 24 Months(24 months)
- Time to Discharge(Discharge)