Laparoscopic SurgeryNCT00762905
Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
A study testing LiquiBand Laparoscopic and Dermabond in people with Laparoscopic Surgery, run by MedLogic Global Limited at 4 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- LiquiBand Laparoscopic and Dermabond
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Apr 2006to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Royal Devon and Exeter Hospital (Wonford
Exeter, Devon, EX2 5DW
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
Huddesfield Royal Infirmary
Huddersfield, West Yorkshire, HD3 3FA
Milton Keynes General Hospital
Milton Keynes, Bucks, MK6 5LD
About this study
Official title: A Prospective, Randomised, Controlled, Double-masked, Multi-center Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
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.
Read the 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.
- Conditions
- Laparoscopic Surgery
- Being tested
- LiquiBand Laparoscopic, Dermabond
- Keywords
- cyanoacrylate, LiquiBand Laparoscopic, Dermabond, The rate of complete dermal apposition, The rate of wound infections and wound dehiscence, The rate of optimal cosmesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiquiBand LaparoscopicDevice
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.
DermabondDevice
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 group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | LiquiBand Laparoscopic Receives: Device: LiquiBand Laparoscopic |
| 2 | Active comparator | Dermabond Receives: Device: Dermabond |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 to 10 months
Secondary outcomes (1)
Time to close incision Patient and user satisfaction
Measured: 8 to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startApr 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedLogic Global Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Stenton, Study director, Sponsor Name Pending
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762905
- Sponsor's protocol ID
- MDL-0601
- Status last verified
- Jan 2010
- First submitted
- 26 Sep 2008
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24128996
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Controlled, Double-masked, Multi-center Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
- ClinicalTrials.gov ID
- NCT00762905
- Acronym / sponsor ID
- MDL-0601
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- MedLogic Global LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: LiquiBand LaparoscopicLiquiBand Laparoscopic |
| 2 | Active comparator | Device: DermabondDermabond |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiquiBand LaparoscopicLiquiBand 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 | 1 |
| DermabondHigh 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. | Device | 2 |
Primary outcome
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
1 secondary outcome
Time to close incision Patient and user satisfaction
Time frame: 8 to 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Derived from this study: PubMed 24128996Kent 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Stenton study director
Sponsor Name Pending
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiquiBand Laparoscopic and Dermabond in people with Laparoscopic Surgery, run by MedLogic Global Limited at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 8 to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00762905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.