Mesh Augmented Reinforcement of Abdominal Wall Suture Line in Patients Undergoing Midline Laparotomy to Limit the Rate of Incisional Hernia Occurrence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 123
- 试验地点
- 26
- 主要终点
- Incisional Hernia Rate
研究概览
简要总结
The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II). Data from this study will be used to support market applications and European post-market clinical follow-up needs (PMCF). The indication under investigation is reinforcement of midline laparotomy to limit the rate of incisional hernia (IH) in clean and clean-contaminated surgeries (CDC Classification I and II).
详细描述
The primary objective of this investigation is to evaluate the performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after elective midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II) at 12 months post-operatively and to demonstrate expected performance in terms of rate of IH occurrence relative to a performance goal (based on historical data on primary laparotomy incision suture closure with small bites only).
The secondary objectives are to evaluate the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after elective midline laparotomy in clean and clean contaminated fields (CDC Classification I and II) within 60 months postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Subject has provided informed consent.
- •Subject is ≥18 years of age at the time of consent.
- •Subject will be undergoing an elective surgery with a planned/possible midline laparotomy with retrorectus mesh placement.
- •3a. Subject will be undergoing an elective laparoscopy with a planned possibility of a conversion to midline laparotomy or an elective laparoscopy with a planned possible midline laparotomy for specimen extraction.
- •Pre-Operative
排除标准
- •Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death
- •Subject has a history of allergic reactions after application of poly-L-lactide, poly-trimethylene carbonate copolymers (PLLA/TMC)
- •Subject is pregnant or is planning pregnancy during study duration period (Females of child-bearing potential will be required to provide either a urine or serum pregnancy test (except for subjects who are surgically sterile or are at least 2 years postmenopausal)) 3a. Subject is breastfeeding or is planning to breastfeed during the study duration period
- •Subject is unable or unwilling to comply with the study requirements or follow-up schedule
- •Subject is scheduled for another planned surgery, and subsequent surgery would jeopardize previous application of study treatment
- •Subject with a body mass index (BMI) > 45 kg/m2
- •Subjects with the following medical interventions/medical conditions are excluded from participation in the study: uncontrolled diabetes (hemoglobin A1c (Hb1Ac) > 60mmol/mol), cirrhosis, stoma wearers
- •Concomitant ostomy (stoma creation or closure)
- •Subject who had received a mesh in a previous ventral hernia repair or has an existing ventral hernia > 2 cm
- •Subject with a life expectancy inferior to the study follow-up duration (36 months)
- •Study procedure is a relaparotomy within 30 days of previous abdominal surgery
- •Subject with an American Society of Anesthesiologists (ASA) scores higher than 3
- •Subject has participated in an investigational drug study within the washout period of the drug or in a device study that would interfere with mesh implantation or assessment of Incisional Hernia
- •Subject with current chemo and/or radiation therapy within 2 weeks of procedure
- •Only exclusion of chemotherapeutic drugs that have:
- •Cytotoxic effect and/or
- •Inhibit of cell replication and/or
- •Impaired tissue healing
- •Subject with any history of ascites
- •Subject has a medical condition that precludes the patient from participation in the opinion of the investigator
- •Subject is undergoing a vascular procedure other than abdominal aortic aneurysm (AAA) surgery (i.e, only AAA surgeries accepted)
- •Intraoperative Exclusion criteria
- •Subject's study procedure is in a contaminated or infected site as assessed by the Investigator(s) (CDC Class 3 and 4)
- •Abdomen is left open at the end of the procedure
- •Subject has an unsuspected ventral hernia >2cm encountered at the time of laparotomy
- •Inability to close the anterior fascia or keep the mesh securely out of the peritoneal cavity
- •Second-look procedure planned
- •Cases requiring a full-thickness partial resection of the abdominal wall (in particular the midline) because of involvement in neoplastic process or complex fistula
- •Inoperable tumor/poor prognostic cancer/patient non curatively treated
- •Subject has a suture length to wound length ratio< 3.5/1
- •Subject has any ongoing infection at the time of the surgery, that is uncontrolled and/or requiring treatment such as antibiotics
- •Subject was not implanted with Deternia™ Self Gripping Resorbable Mesh
- •Subject requires more than 1 mesh
研究组 & 干预措施
Hernia prevention cohort
single arm study, no control arm
干预措施: Self-Gripping Resorbable Mesh (Device)
结局指标
主要结局
Incisional Hernia Rate
时间窗: 12 months
Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam
次要结局
- Time to Incisional Hernia(From the surgery to the 36-month visit)
- Time to other adverse device effects (ADE)(From the surgery to the 36-month visit)
- EQ-5D-5L quality of life (QoL)(Baseline and at 3-, 6-, 12-, 24-, and 36- months)
- Pain at the site of surgery evaluated with Numeric Rating Scale (NRS)(baseline (screening), discharge (post-surgery up to 3-mo) and at 3-, 6-, 12-, 24-, and 36- months)
- Incisional Hernia Rate(3-, 6-, 12-, 24-, and 36- months)
- Incidence of all adverse device effects (ADEs)(Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months)
- Incidence of adverse events (AEs) of interest(Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months)
- Surgeon Satisfaction(Day 0, post-operative)
- Hospital length of stay(Hospital admission to hospital discharge (post-surgery up to 3-mo))
- Readmission and reoperation rate(From the surgery to the 36-month visit)
- Incisional Hernia Rate(24- and 36-months)
- Time to Incisional Hernia(From the surgery to the 60-month visit)
- Time to other adverse device effects (ADE)(From the surgery to the 60-month visit)
- Incidence of all adverse device effects (ADEs)(Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, 36-, 48- and 60- months)
- Incidence of adverse events (AEs) of interest(Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, 36-, 48- and 60- months)
- Readmission and reoperation rate(From the surgery to the 60-month visit)
- Incisional Hernia Rate(48- and 60-months)