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

January 11, 2010 updated by: MedLogic Global Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

460

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Bucks
      • Milton Keynes, Bucks, United Kingdom, MK6 5LD
        • Milton Keynes General Hospital
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital (Wonford
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
    • West Yorkshire
      • Huddersfield, West Yorkshire, United Kingdom, HD3 3FA
        • Huddesfield Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 8 to 10 months
8 to 10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to close incision Patient and user satisfaction
Time Frame: 8 to 10 months
8 to 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedLogic Global Limited

Investigators

  • Study Director: Richard Stenton, Sponsor Name Pending

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDL-0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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