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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

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Time to close incision Patient and user satisfaction [ Time Frame: 8 to 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762905


Locations
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United Kingdom
Milton Keynes General Hospital
Milton Keynes, Bucks, United Kingdom, MK6 5LD
Royal Devon and Exeter Hospital (Wonford
Exeter, Devon, United Kingdom, EX2 5DW
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX
Huddesfield Royal Infirmary
Huddersfield, West Yorkshire, United Kingdom, HD3 3FA
Sponsors and Collaborators
MedLogic Global Limited
Investigators
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Study Director: Richard Stenton Sponsor Name Pending
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Richard Stenton, MedLogic Global Limited
ClinicalTrials.gov Identifier: NCT00762905    
Other Study ID Numbers: MDL-0601
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: January 2010
Keywords provided by MedLogic Global Limited:
cyanoacrylate
LiquiBand Laparoscopic
Dermabond
The rate of complete dermal apposition
The rate of wound infections and wound dehiscence
The rate of optimal cosmesis
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries