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

MedLogic Global

Status: Completed

Conditions: Laparoscopic Surgery

Treatments: Device: Dermabond; Device: LiquiBand Laparoscopic

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762905

MDL-0601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 2 patient groups

1

Active Comparator group

Description:

LiquiBand Laparoscopic

Treatment:

Device: LiquiBand Laparoscopic

2

Active Comparator group

Description:

Dermabond

Treatment:

Device: Dermabond