Status:
COMPLETED
Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
Lead Sponsor:
MedLogic Global Limited
Conditions:
Laparoscopic Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 Laparoscop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00762905
Start Date
April 1 2006
End Date
May 1 2009
Last Update
January 12 2010
Active Locations (4)
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1
Milton Keynes General Hospital
Milton Keynes, Bucks, United Kingdom, MK6 5LD
2
Royal Devon and Exeter Hospital (Wonford
Exeter, Devon, United Kingdom, EX2 5DW
3
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX
4
Huddesfield Royal Infirmary
Huddersfield, West Yorkshire, United Kingdom, HD3 3FA