Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Inc… (NCT00762905) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
United Kingdom460 participantsStarted 2006-04
Plain-language summary
To evaluate the effectiveness, safety, and utility of LiquiBand Laparoscopicâ„¢ in relation to a currently approved active control product (High Viscosity DermaBond). Specifically, the study is powered to demonstrate that LiquiBand Laparoscopicâ„¢ is not inferior to DermaBond in the rates of infection, dehiscence, cosmesis and apposition of the skin.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
What they're measuring
1
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