Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 1:43 PM
Study NCT ID:
NCT00762905
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2008-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-11', 'studyFirstSubmitDate': '2008-09-26', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'measure': 'Time to close incision Patient and user satisfaction', 'timeFrame': '8 to 10 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cyanoacrylate', 'LiquiBand Laparoscopic', 'Dermabond', 'The rate of complete dermal apposition', 'The rate of wound infections and wound dehiscence', 'The rate of optimal cosmesis'], 'conditions': ['Laparoscopic Surgery']}, 'referencesModule': {'references': [{'pmid': '24128996', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for a laparoscopic surgical procedure\n* Aged 18 years or older\n* Agree to return to 2-weeks (3 days) post-procedure follow-up visit\n* Agree to return to 3-month (5 days) post-procedure follow-up visit\n* Able and willing to give informed consent and to comply with all study requirements\n\nExclusion Criteria:\n\n* Known sensitivity to cyanoacrylate, formaldehyde or acetone products,\n* Surgical procedures involving mucus membranes or eyes\n* History of skin rashes or exfoliative condition at time of procedure\n* History of keloid formation or hypertrophy\n* Currently on immunosuppressive therapy\n* Decubitus ulcer\n* Pregnant or nursing.\n* Participated in an investigational drug or device study within the past 3 months\n* Conditions known to interfere with wound healing:\n* Diabetes, Type I or II\n* Advanced chronic renal insufficiency (GFR greater than 25 mL/min or with clinical signs of azotemia), uremia or endstage renal disease\n* Advanced liver failure or cirrhosis (Child-Pugh score of B or C)\n* Advanced malignancy, or cancer patients currently receiving chemotherapy (within 30 days of procedure)\n* History of radiation therapy to the study area\n* Advanced COPD (FEV greater than 1 litre and or PaO2 60 mmHg)\n* Suspected infection at incision site\n* Peripheral vascular disease\n* Corticosteroid therapy\n* Morbid obesity (50-100 percent or 100 pounds above their ideal body weight and/or a BMI value greater than 40)\n* Blood clotting disorders (e.g. Haemophilia)\n* Wounds under high tension forces (over joints)\n* Life expectancy of greater than 3 months\n* ASA level of 4 or 5'}, 'identificationModule': {'nctId': 'NCT00762905', 'briefTitle': 'Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedLogic Global Limited'}, 'officialTitle': 'A Prospective, Randomised, Controlled, Double-masked, Multi-center Clinical Trial of MedLogic LiquiBand Laparoscopic Versus Dermabond in the Closure of Surgical Incisions', 'orgStudyIdInfo': {'id': 'MDL-0601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'LiquiBand Laparoscopic', 'interventionNames': ['Device: LiquiBand Laparoscopic']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Dermabond', 'interventionNames': ['Device: Dermabond']}], 'interventions': [{'name': 'LiquiBand Laparoscopic', 'type': 'DEVICE', '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.', 'armGroupLabels': ['1']}, {'name': 'Dermabond', 'type': 'DEVICE', '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.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'MK6 5LD', 'city': 'Milton Keynes', 'state': 'Bucks', 'country': 'United Kingdom', 'facility': 'Milton Keynes General Hospital', 'geoPoint': {'lat': 52.04172, 'lon': -0.75583}}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter Hospital (Wonford', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'HD3 3FA', 'city': 'Huddersfield', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Huddesfield Royal Infirmary', 'geoPoint': {'lat': 53.64904, 'lon': -1.78416}}], 'overallOfficials': [{'name': 'Richard Stenton', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor Name Pending'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedLogic Global Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Richard Stenton', 'oldOrganization': 'MedLogic Global Limited'}}}}