Laparoscopic Surgery
Conditions
Keywords
cyanoacrylate, LiquiBand Laparoscopic, Dermabond, The rate of complete dermal apposition, The rate of wound infections and wound dehiscence, The rate of optimal cosmesis
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.
Interventions
DEVICELiquiBand Laparoscopic
LiquiBand Laparoscopic™ is a sterile, liquid adhesive made up of a blend of n-butyl and 2-octyl cyanoacrylate intended for soft tissue approximation of skin wounds. It is packaged in a sterile, single-use, nylon applicator with internal glass ampoule containing 0.8g of adhesive and sealed in a PETG/Tyvek blister pack. LiquiBand Laparoscopic™ is intended to be applied topically to pre-apposed wound edges. The tissue adhesive sets rapidly (5 - 10 seconds) to hold the wound closed. Following wound closure the product is designed to apply a broad coverage of adhesive to act as a liquid dressing to protect the wound.
DEVICEDermabond
High viscosity DermaBond Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single use applicator packaged in a blister pouch. The applicator is comprised of a crushable glass ampule contained within a plastic vial with attached applicator tip. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes.
Sponsors
MedLogic Global Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Time to close incision Patient and user satisfaction | 8 to 10 months |
Countries
United Kingdom
Outcome results
None listed