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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762905
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : January 12, 2010
Sponsor:
Information provided by:
MedLogic Global Limited

Tracking Information
First Submitted Date  ICMJE September 26, 2008
First Posted Date  ICMJE September 30, 2008
Last Update Posted Date January 12, 2010
Study Start Date  ICMJE April 2006
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2008)
Time to close incision Patient and user satisfaction [ Time Frame: 8 to 10 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
Official Title  ICMJE A Prospective, Randomised, Controlled, Double-masked, Multi-center Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Laparoscopic Surgery
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: 1
    LiquiBand Laparoscopic
    Intervention: Device: LiquiBand Laparoscopic
  • Active Comparator: 2
    Dermabond
    Intervention: Device: Dermabond
Publications * Kent A, Liversedge N, Dobbins B, McWhinnie D, Jan H. A prospective, randomized, controlled, double-masked, multi-center clinical trial of medical adhesives for the closure of laparoscopic incisions. J Minim Invasive Gynecol. 2014 Mar-Apr;21(2):252-8. doi: 10.1016/j.jmig.2013.10.003. Epub 2013 Oct 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 29, 2008)
460
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00762905
Other Study ID Numbers  ICMJE MDL-0601
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Stenton, MedLogic Global Limited
Study Sponsor  ICMJE MedLogic Global Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Richard Stenton Sponsor Name Pending
PRS Account MedLogic Global Limited
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP