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

Primary Purpose

Laparoscopic Surgery

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
LiquiBand Laparoscopic
Dermabond
Sponsored by
MedLogic Global Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Surgery focused on measuring cyanoacrylate, LiquiBand Laparoscopic, Dermabond, The rate of complete dermal apposition, The rate of wound infections and wound dehiscence, The rate of optimal cosmesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Milton Keynes General Hospital
  • Royal Devon and Exeter Hospital (Wonford
  • Royal Surrey County Hospital
  • Huddesfield Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

LiquiBand Laparoscopic

Dermabond

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to close incision Patient and user satisfaction

Full Information

First Posted
September 26, 2008
Last Updated
January 11, 2010
Sponsor
MedLogic Global Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00762905
Brief Title
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

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedLogic Global Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
LiquiBand Laparoscopic
Arm Title
2
Arm Type
Active Comparator
Arm Description
Dermabond
Intervention Type
Device
Intervention Name(s)
LiquiBand Laparoscopic
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Dermabond
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Time to close incision Patient and user satisfaction
Time Frame
8 to 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Stenton
Organizational Affiliation
Sponsor Name Pending
Official's Role
Study Director
Facility Information:
Facility Name
Milton Keynes General Hospital
City
Milton Keynes
State/Province
Bucks
ZIP/Postal Code
MK6 5LD
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital (Wonford
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Huddesfield Royal Infirmary
City
Huddersfield
State/Province
West Yorkshire
ZIP/Postal Code
HD3 3FA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24128996
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.
Results Reference
derived

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

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