A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 32
- 主要终点
- Hernia Recurrence Rate
研究概览
简要总结
Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.
详细描述
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ Mesh in subjects requiring primary ventral, incisional or first-recurrent (protocol version 1.4)/multiply-recurrent (protocol version 2.0) hernia repair in subjects at high risk for complications. Subjects at high risk are defined as having 1 or more of the following co-morbidity conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency.
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
- •Subjects must have met all of the criteria listed below to be enrolled in the study:
- •Subject must have been 18 years of age or older
- •Subject or subject's legally authorized representative must have given written informed consent
- •Subject must have been diagnosed with primary ventral, incisional hernia or first time recurrent ventral or incisional hernia (protocol version 1.4)
- •Subject must be diagnosed with primary ventral, incisional hernia or multiply-recurrent (not to exceed 3 recurrences) ventral or incisional hernia (protocol version 2.0)
- •Subject must have had a hernia greater than 10 cm2 and ≤350 cm2
- •Subject must have been willing to undergo initial ventral, incisional or first recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 1.4)
- •Subject must be willing to undergo initial ventral, incisional or multiply-recurrent incisional hernia repair using retro-rectus or onlay placement (using absorbable suture) with or without Component Separation Technique (CST) (protocol version 2.0)
- •Subject met the criteria for a Class I wound as defined by the CDC (Appendix 4 of the protocol)
- •Subjects must have had 1 or more of the following pre-study conditions:
- •Body Mass Index (BMI) between 30-40 kg/m2, inclusive
- •Active smokers (if attempts to quit smoking within two weeks of surgery have failed and the patient was still an active smoker at the time of surgery)
- •COPD presence on patient self-report
- •Diabetes mellitus
- •Immunosuppression
- •Coronary Artery Disease
- •Chronic corticosteroid use: greater than 6 months systemic use
- •Serum albumin less than 3.4 g/dL
- •Advanced age: 75 years or older
- •Renal insufficiency, defined as serum creatinine concentration ≥2.5 mg/dL
排除标准
- •Subjects were excluded from study enrollment if any of the following criteria were met:
- •Subject's hernia had recurred more than once (protocol version 1.4)
- •Subject has had 4 or more previous hernia repairs (of the index hernia) (protocol version 2.0)
- •The subject had peritonitis
- •The subject was on or suspected to be placed on chemotherapy medications during any part of the study
- •The subject's Body Mass Index (BMI) was greater than 40 kg/m2
- •The subject had cirrhosis of the liver and/or ascites
- •Subject was American Society of Anesthesiology Class 4 or 5
- •Subject was known to be infected with human immunodeficiency virus (HIV)
- •Subject had a life expectancy of less than 2 years at the time of enrollment
- •Subject had any condition that, in the opinion of the Investigator, precluded the use of the study device, precluded the subject from completing the follow-up requirements
- •Subject's hernia repair utilized intraabdominal mesh placement
- •Subject had a surgical wound classified as Class II (Clean-Contaminated), Class III (Contaminated) or Class IV (Dirty-Contaminated) as defined by the CDC (Appendix 4 of the protocol)
- •Subject had an active or latent systemic infection
- •Subject required surgical bridge repair as the sole repair
- •Subject was pregnant or had plans to become pregnant during the study period or was breastfeeding
- •Subject had enrolled in another clinical study within the last 30 days
- •Subject was part of the site personnel directly involved with this study
- •Subject had a known allergy to the test device or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate were avoided).
结局指标
主要结局
Hernia Recurrence Rate
时间窗: 60 Months
Hernia recurrence rates will be assessed by physical examination at each study visit through 60 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan will be evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.
Surgical Site Infections
时间窗: 60 Months
Infections at the surgical site will be assessed by physical examination at each study visit through 60 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the CDC guidelines for superficial and deep surgical site infections
次要结局
- Rate of Re-operation Due to the Index Hernia Repair(60 Months)
- Length of Hospital Stay(35 days)
- Device Related Adverse Events(60 Months)
- Surgical Procedure Time as Measured From Incision to Closure(1 day)
- Pain Visual Analog Scale(60 Months)
- Carolinas Comfort Scale® (CCS)(60 Months)
- SF-12 Questionnaire(60 Months)