Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions

Not Applicable

Completed

• Conditions: Laparoscopic Surgery

• Registration Number: NCT00762905
• Lead Sponsor: MedLogic Global Limited

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 to demonstrate that LiquiBand Laparoscopic™ is not inferior to DermaBond in the rates of infection, dehiscence, cosmesis and apposition of the skin.

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 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.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-11
• Last Update Posted: 2010-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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)
• Wounds under high tension forces (over joints)
• Life expectancy of greater than 3 months
• ASA level of 4 or 5

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	8 to 10 months

Secondary Outcome Measures

Name	Time	Method
Time to close incision Patient and user satisfaction	8 to 10 months

Trial Locations

Locations (4)

Milton Keynes General Hospital; 🇬🇧 Milton Keynes, Bucks, United Kingdom

Royal Devon and Exeter Hospital (Wonford; 🇬🇧 Exeter, Devon, United Kingdom

Royal Surrey County Hospital; 🇬🇧 Guildford, Surrey, United Kingdom

Huddesfield Royal Infirmary; 🇬🇧 Huddersfield, West Yorkshire, United Kingdom