A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 11
- 主要终点
- modified American Fertility Society (mAFS) score at the posterior uterus
研究概览
简要总结
The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas
详细描述
Postoperative adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of Adhibit™ Adhesion Prevention Gel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing myomectomy via laparotomy or laparoscopy. Subjects were scheduled to return within 6-8 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postoperative adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Preoperatively, subjects must have had:
- •Been scheduled for myomectomy via laparotomy or laparoscopy.
- •Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 6 to 8 weeks following myomectomy.
- •Been >=18 years of age.
- •Provided voluntary written informed consent.
- •Been willing to comply with all aspects of the treatment and evaluation schedule.
- •Intra-operatively, subjects must have had:
- •Had at least one 2 cm incision length on posterior uterine surface, which may include the fundal surface.
排除标准
- •Preoperatively, subjects must not have had:
- •Been pregnant.
- •Had a pelvic malignancy.
- •Had acute pelvic inflammatory disease.
- •Had an immune compromised condition.
- •Been a participant in another clinical research study which the investigator believed could interfere with the purpose of this study.
- •Been given corticosteroids intra-operatively or during the course of the postoperative study follow up.
- •Intra-operatively, subjects must not have had:
- •Had a pelvic malignancy.
- •Had a pelvic or abdominal infection.
- •Had acute pelvic inflammatory disease.
- •Received any adhesion prevention adjuvants or barriers, or peritoneal instillates containing corticosteroids, NSAIDs, or Dextran.
结局指标
主要结局
modified American Fertility Society (mAFS) score at the posterior uterus
时间窗: 6-8 weeks following primary myomectomy surgery
次要结局
- adhesion extent and tenacity scores at the posterior uterus(6-8 weeks following primary myomectomy surgery)