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

Sponsor

MedLogic Global Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT00762905

Collaborator

(none)

460

Enrollment

Locations

Arms

Duration (Months)

115

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Surgery	Device: LiquiBand Laparoscopic Device: Dermabond	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

460 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomised, Controlled, Double-masked, Multi-center Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 LiquiBand Laparoscopic	Device: 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.
Active Comparator: 2 Dermabond	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.

Arm

Intervention/Treatment

Active Comparator: 1

LiquiBand Laparoscopic

Device: 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.

Active Comparator: 2

Dermabond

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.

Outcome Measures

Primary Outcome Measures

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

Time to close incision Patient and user satisfaction [8 to 10 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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