NCT00646412已完成1 期
A Prospective, Randomised, Controlled, Single-blind Phase I-II Clinical Trial on the Safety of A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Occurrence of wound healing impairment and/or postoperative peritonitis after surgery
研究概览
简要总结
The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy.
详细描述
Primary Objective:
• first assessment of the safety of applying A-Part® Gel as adhesion prophylaxis after major abdominal surgery by specific observation of two major complications of abdominal surgery (wound healing impairment, and/or postoperative peritonitis) in comparison to a control group.
Secondary Objectives:
- To further evaluate the safety of A-Part® Gel by comparing the incidences of adverse events between the treatment groups (with special attention to anastomosis leakage)
- To explore the efficacy of A-Part® Gel in reducing post-surgical adhesions after median laparotomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Patients of both sexes, who are candidates for a primary and elective median abdominal incision with a length of ≥ 15 cm
- •Age ≥ 18 years
- •Patients who are legally capable and able to understand the nature, significance and consequences of the study and are willing and able to comply with the study protocol and the follow up
- •Written informed consent obtained according to international guidelines and local law. Informed consent will be documented by the volunteer's dated signature, which will be also signed and dated by the investigator
- •Patients with an expected survival time >12 months
- •For female adults of reproductive potential: Negative pregnancy test at visit 1 and sufficient contraception from time of written consent up to at least 4 months
排除标准
- •Patients with a previous median laparotomy and any other abdominal surgery (exceptions: previous laparoscopic appendectomy, cholecystectomy, inguinal hernia repair, gynecological tube sterilisation)
- •Patients with a known history of adhesions or a known history of peritonitis
- •Patients with a known sensitivity to polyvinylalcohol and/or carboxymethylcellulose
- •Simultaneous participation of the patient in another clinical trial or participation in a clinical trial within the last 30 days prior to signing the Informed consent form
- •Patients with ASA > 3 or emergency patients (including severe psychic diesease)
- •Patients with ascites > 200 ml
- •Patients with peritoneal carcinosis or peritoneal dialysis
- •Patients with a diagnosed peritonitis, intra-abdominal abscess or other intra-abdominal infection
- •Patient with renal impairment (Creatinine > 1.3 mg/dl)
- •Patients with systemic immunosuppression (e.g. hydrocortisone > 50mg daily [oral/i.v.] at any day or any equivalent dosage; other immunosuppressants like Azathioprin, Mycophenolatmofetil, Ciclosporin, Everolimus, Methotrexat, ect.), chemotherapy or radiotherapy within the last 2 weeks prior to surgery
- •Surgical procedures or patient characteristics which require insertion of more than 2 intra-abdominal drainages
- •Women within a pregnancy or breast-feeding mothers or women who wish to get pregnant within the next 4 months after surgery or women without sufficient contraceptive care
结局指标
主要结局
Occurrence of wound healing impairment and/or postoperative peritonitis after surgery
时间窗: 28 (+10) days
次要结局
- Adhesion rates along the scar examined by ultrasound-assessment(14 days (range: day 7-14), 28 days (+10 days), 3 months (± 14 days))
- Occurrence of anastomosis leakage after surgery(within 28 (+10) days)
- Occurrence of adverse events (AEs) and serious adverse events (SAEs) after surgery(postoperative hospital stay and up to 3 months)
研究者
研究点 (2)
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