NCT00820040终止2 期
To Examine the Feasibility of Using Permacol® Surgical Implant in the Repair of Abdominal Wall Defects After Removal of Chronic Infect Prosthetic Mesh
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 6
- 主要终点
- Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening
研究概览
简要总结
This pilot study is to examine the feasibility of using Permacol Surgical Implant in the repair of abdominal wall defects after removal of infected prosthetic mesh
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Have given written Informed Consent
- •Be 18-85 years of age (inclusive)
- •Have prosthetic mesh that is in proximity to an infected wound that has failed conservative management for at least 3 months, with mesh exposure and a draining wound, or that is in proximity to an abscess that requires operative intervention.
- •Have a wound characterized by purulent discharge, positive gram stain or positive culture to document infection
- •Be a candidate for surgical removal of infected mesh placed for repair of ventral/incisional hernias and concomitant abdominal wall reconstruction
- •Have an ASA Score ≤3
- •Have a body mass index (BMI) between 16.5 and 40 inclusive
- •Be a candidate for anticipated primary approximation of skin/wound
- •Have a life expectancy of at least 18 months
- •Be willing to allow biopsy of implant if secondary wound opening is performed or spontaneous implant exposure occurs
排除标准
- •Have loss of abdominal domain such that the operation would be impractical or would adversely effect respiratory or cardiovascular function to an unacceptable degree
- •Have an enterocutaneous fistula in proximity to wound/mesh
- •Be a candidate for emergency surgery that would make giving valid Informed Consent impractical
- •Be currently taking part in another clinical study that conflicts with the current study
- •Have known allergy to porcine collagen products
- •Have active generalized peritonitis or intraperitoneal sepsis
- •Have active necrotizing fasciitis
- •Have active abdominal compartment syndrome
- •Have active untreated metabolic or systemic illness
- •Report unintentional weight loss >10% of body weight in the previous 90 days
- •Have known collagen metabolism disorder.(e.g., Ehlers-Danlos syndrome)
- •Have known altered immune response (e.g., HIV or other immunodeficiency disorder))
- •Have chronic renal failure
- •Have known active malignancy present
- •Have history of systemic chemotherapy within previous 1 year
- •Have lifetime history of radiation to the abdomen, pelvis or thorax
- •Have inguinal or groin hernia as primary diagnosis
- •Be currently pregnant or planning to become pregnant during study period
- •Be unable to give valid informed consent or comply with required follow- up schedule
- •Suffer from mental capacity sufficiently severe to make informed consent unobtainable
结局指标
主要结局
Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening
时间窗: 12 months
The primary objective of this study was hernia recurrence or surgical site infection as assessed by a CT scan 12 months following surgery.Hernia recurrence was defined as any abnormal abdominal protrusion, as assessed by 12 month CT. Surgical site infection requiring wound opening was defined as abscess formation or drainage that required surgical wound opening. Wound opening was defined as surgical entry into the wound.
次要结局
- Subjects Having Permacol Implants Removed or Debrided After Implantation(12 months)
研究者
研究点 (6)
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