Clinical trial NCT00762905: Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgery
Keywords: cyanoacrylate
LiquiBand Laparoscopic
Dermabond
The rate of complete dermal apposition
The rate of wound infections and wound dehiscence
The rate of optimal cosmesis
Lead sponsor: MedLogic Global Limited
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 8 to 10 months
Secondary outcomes:
measure: Time to close incision Patient and user satisfaction
timeFrame: 8 to 10 months
Other outcomes:
Locations:
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes General Hospital
state: Bucks
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford
state: Devon
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
state: Surrey
city: Huddersfield
country: United Kingdom
facility: Huddesfield Royal Infirmary
state: West Yorkshire
Study officials:
affiliation: Sponsor Name Pending
name: Richard Stenton
role: STUDY_DIRECTOR
References:
citation: 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.