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

Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762905
• Other study ID #: MDL-0601
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: January 11, 2010
• Start date: April 2006
• Est. completion date: May 2009

Study information

• Verified date: January 2010
• Source: MedLogic Global Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laparoscopic Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
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	Milton Keynes General Hospital	Milton Keynes	Bucks

Sponsors (1)

Lead Sponsor	Collaborator
MedLogic Global Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Time to close incision Patient and user satisfaction		8 to 10 months	No