Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
A Prospective, Randomised, Controlled, Double-masked, Multi-center Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
1 other identifier
interventional
460
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2006
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedJanuary 12, 2010
January 1, 2010
3.1 years
September 26, 2008
January 11, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
8 to 10 months
Secondary Outcomes (1)
Time to close incision Patient and user satisfaction
8 to 10 months
Study Arms (2)
1
ACTIVE COMPARATORLiquiBand Laparoscopic
2
ACTIVE COMPARATORDermabond
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Milton Keynes General Hospital
Milton Keynes, Bucks, MK6 5LD, United Kingdom
Royal Devon and Exeter Hospital (Wonford
Exeter, Devon, EX2 5DW, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Huddesfield Royal Infirmary
Huddersfield, West Yorkshire, HD3 3FA, United Kingdom
Related Publications (1)
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.
PMID: 24128996DERIVED
Study Officials
- STUDY DIRECTOR
Richard Stenton
Sponsor Name Pending
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
April 1, 2006
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
January 12, 2010
Record last verified: 2010-01