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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

LiquiBand Laparoscopic

Group Type ACTIVE_COMPARATOR

LiquiBand Laparoscopic

Intervention Type DEVICE

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.

2

Dermabond

Group Type ACTIVE_COMPARATOR

Dermabond

Intervention Type DEVICE

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.

Interventions

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LiquiBand 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.

Intervention Type DEVICE

Dermabond

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No