Randomized, Controlled Trial Comparing Separation of Components Repair With Retrorectus Gentrix™ Surgical Matrix Versus Biological or Prosthetic Mesh for Open Ventral Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 6
- 主要终点
- Incidence of incisional hernia recurrence
研究概览
简要总结
The hypothesis for this study is complex incisional hernia repair using the separation of components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will lead to fewer incisional hernia recurrences and fewer wound complications compared to the same incisional hernia repair techniques reinforced with other prosthetic or biologically-derived mesh.
详细描述
Biological and prosthetic mesh products are extensively used in hernia repairs. However, they also have their limitations. Potential complications associated with prosthetic mesh for hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. Potential complications associated with biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent herniation. This study is a two-arm, randomized, controlled trial comparing separation of components repair with retrorectus Gentrix™ Surgical Matrix versus biological or prosthetic mesh for open ventral hernia repair.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ≥ 18 years old.
- •American Society of Anesthesiologists (ASA) physical status classification of I, II, III or IV.
- •Able to provide informed consent in English or Spanish.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Body Mass Index (BMI) =<
- •Incisional hernia from a midline incision ≥ 4 cm in greatest diameter, or any recurrent incisional hernia.
排除标准
- •Any other type of ventral hernia, such as umbilical, epigastric or Spigelian hernia.
- •Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
- •Allergy or hypersensitivity to materials in porcine-based study products, biological or prosthetic meshes, or personal preference.
- •Contraindications to general anesthesia.
- •Patient undergoing any emergency surgery prior to treatment.
- •Severe comorbid conditions likely to limit survival to less than 3 years in the opinion of the Investigator.
- •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 with abdominal wall mobilization or component separation; confirmed intra-operatively.
- •History of malignancy within the past 5 years except for non-melanoma skin cancer.
- •Known active malignancy present and/or had chemotherapy 12 weeks prior to screening or planned chemotherapy within 12 weeks of treatment with exception of basal cell carcinoma, squamous cell carcinoma, or prostate cancer in situ.
- •Cirrhosis with or without ascites.
- •Received high dose steroids (>/=100mg of prednisone) within the past 6 weeks of screening.
- •Uncontrolled diabetes (i.e. known HbA1C value > 7% within the prior 6 weeks of the Screening Visit).
- •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.
- •Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.
- •Suspected presence of enterocutaneous fistula.
- •Planned use of external VAC dressing intra-operatively.
- •Suspected bowel obstruction (partial or intermittent), strangulation, peritonitis, or perforation.
- •Active necrotizing fasciitis or any other known active local or systemic infection.
- •Subject report of 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 treatment in this trial.
结局指标
主要结局
Incidence of incisional hernia recurrence
时间窗: 2 years from study incisional hernia repair
次要结局
- Mean Visual Analog Scale score(2 years from study incisional hernia repair)
- Mean procedure time(duration of surgery (incisional hernia repair))
- Mean total cost of surgery for primary admission(duration of surgery (incisional hernia repair))
- Incidence of wound complications(90 days from study incisional hernia repair)
- Incidence of enterocutaneous fistula formation(2 years from study incisional hernia repair)
- Mean Carolinas Comfort Scale score(2 years from study incisional hernia repair)
- Time to incisional hernia recurrence(2 years from study incisional hernia repair)
- Mean mesh deployment time(duration of surgery (incisional hernia repair))
- Mean total cost of narcotic usage for primary admission(duration of hospitalization for incisional hernia repair)
- Mean total cost of hospitalization for primary admission(duration of hospitalization for incisional hernia repair)
- Mean total cost of readmissions(2 years from study incisional hernia repair)