Clinical Study to Evaluate LiquiBand® Exceed™ and LiquiBand® Rapid™ for Closure of Surgical Incisions Associated With Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 6
- 主要终点
- Incidence of wound dehiscence
研究概览
简要总结
The purpose of this post market study is to evaluate the performance and safety of LiquiBand® Exceed™ and LiquiBand® Rapid™ for closure of surgical incisions associated with abdominal surgery.
详细描述
LiquiBand® Exceed™ and LiquiBand® Rapid™ are the "study" devices. The study devices are an adhesive used to close surgical wounds. When the adhesive is applied to the skin, it polymerizes (forms a chemical bond) within minutes due to the moisture on the skin's surface and allows the wound edges to remain in the correct position. The use of the study devices are not "investigational" (experimental) because it is already cleared for doctors to use for surgical wound closure in the United States of America.
In this study, LiquiBand® Exceed™ and LiquiBand® Rapid™ will be used to close surgical wounds following general abdominal surgery. Subjects will be followed up for 14-days post surgery, and safety and performance of the study device will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients who meet all of these criteria at time of enrollment may be included in the investigation:
- •Subject is ≥ 18 years of age
- •Subject is to undergo general abdominal surgery
- •Planned incision(s) are expected to be 4cm or greater in length
- •Subject is willing and able to comply with the protocol and follow up period
- •Subject is willing and able to give written informed consent
排除标准
- •Patients who meet any one of these criteria will be excluded from the study:
- •Subject is pregnant or nursing
- •Subject has inadequate or unsuitable tissue e.g. due to radiation damage, ulceration compromised vascularity, history of compromised wound heal.
- •Subject has a sensitivity to cyanoacrylates or formaldehyde
- •Subject has a known sensitivity to topical skin adhesives
- •Subject has active or potential infection at the surgical site
- •Subject has a history of keloid formation
- •Subject has a known vitamin C or zinc deficiency
- •Subject has a connective tissue disorder
- •Subject has uncontrolled diabetes mellitus
结局指标
主要结局
Incidence of wound dehiscence
时间窗: 14 days post-surgery
Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator
次要结局
- Cosmetic outcome(14-days post-surgery)
- Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs(14-days post-surgery)
- Surgeon satisfaction with the device(Day 0)