A Prospective, Randomised, Controlled, Double-masked, Multi-center Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 460
- 试验地点
- 8
- 主要终点
- The rate of complete dermal apposition at 2-weeks (3 days) To compare the rates of wound infections and wound dehiscence The rate of optimal cosmesis (score=6) at 3-months (± 5 days) will be calculated
研究概览
简要总结
To evaluate the effectiveness, safety, and utility of LiquiBand Laparoscopic™ in relation to a currently approved active control product (High Viscosity DermaBond). Specifically, the study is powered to demonstrate that LiquiBand Laparoscopic™ is not inferior to DermaBond in the rates of infection, dehiscence, cosmesis and apposition of the skin.
详细描述
This is a prospective, randomized, controlled, double-masked multi-center clinical trial. Patients requiring laparoscopic surgery will be enrolled and randomized to receive either LiquiBand Laparoscopic™ or DermaBond High Viscosity for incision closure. No other closure methods will be allowed. All eligible laparoscopic incisions per patient will be enrolled. Patients will be followed at 2 weeks and 3 months post-procedure to assess wound characteristics, wound infection, wound dehiscence and at 3 months for cosmesis. The study will be double-masked in that both the wound evaluator and patient will be masked to the randomized study treatment assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Scheduled for a laparoscopic surgical procedure
- •Aged 18 years or older
- •Agree to return to 2-weeks (3 days) post-procedure follow-up visit
- •Agree to return to 3-month (5 days) post-procedure follow-up visit
- •Able and willing to give informed consent and to comply with all study requirements
排除标准
- •Known sensitivity to cyanoacrylate, formaldehyde or acetone products,
- •Surgical procedures involving mucus membranes or eyes
- •History of skin rashes or exfoliative condition at time of procedure
- •History of keloid formation or hypertrophy
- •Currently on immunosuppressive therapy
- •Decubitus ulcer
- •Pregnant or nursing.
- •Participated in an investigational drug or device study within the past 3 months
- •Conditions known to interfere with wound healing:
- •Diabetes, Type I or II
- •Advanced chronic renal insufficiency (GFR greater than 25 mL/min or with clinical signs of azotemia), uremia or endstage renal disease
- •Advanced liver failure or cirrhosis (Child-Pugh score of B or C)
- •Advanced malignancy, or cancer patients currently receiving chemotherapy (within 30 days of procedure)
- •History of radiation therapy to the study area
- •Advanced COPD (FEV greater than 1 litre and or PaO2 60 mmHg)
- •Suspected infection at incision site
- •Peripheral vascular disease
- •Corticosteroid therapy
- •Morbid obesity (50-100 percent or 100 pounds above their ideal body weight and/or a BMI value greater than 40)
- •Blood clotting disorders (e.g. Haemophilia)
- •Wounds under high tension forces (over joints)
- •Life expectancy of greater than 3 months
- •ASA level of 4 or 5
结局指标
主要结局
The rate of complete dermal apposition at 2-weeks (3 days) To compare the rates of wound infections and wound dehiscence The rate of optimal cosmesis (score=6) at 3-months (± 5 days) will be calculated
时间窗: 8 to 10 months
次要结局
- Time to close incision Patient and user satisfaction(8 to 10 months)