Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
Study NCT ID:
NCT03843866
Status:
UNKNOWN
Last Update Posted:
2019-02-20
First Post:
2019-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sutures Versus Glue in Laparoscopic Port Site Closure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-09-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2019-02-13', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cosmesis', 'timeFrame': '6 months', 'description': 'Cosmetic outcome being graded by patient and clinician via questionnaire. Observer scar assessment form (1-10) 1 = worst result possible, 10 being the best result possible.'}], 'secondaryOutcomes': [{'measure': 'Surgical site infection (SSI).', 'timeFrame': '6 months', 'description': 'Any superficial site infection which requires antibiotic use or wound complication such as dehisence. This information will be obtained from clinic.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cosmetic Outcome', 'Infection', 'Cost']}, 'referencesModule': {'references': [{'pmid': '40102141', 'type': 'DERIVED', 'citation': "Ramjit SE, Davey MG, Keelan S, Herlihy E, Dromey M, Garvey C, Nugent TS, Fawaz A, O'Connell L, Cunningham M, Fahy M, Ryan EJ, Moran B, Aljohmani L, Narayanasamy J, Kelly ME, Healy C, Donohoe C, Ravi N, Neary P, Reynolds JV, Donlon NE. Evaluating the use of absorbable sutures versus sTaples versus tIssue glue in laparoscopic port skin closure (STILS) trial: A prospective, multi-centre randomised clinical trial (RCT). Surgeon. 2025 Oct;23(5):306-312. doi: 10.1016/j.surge.2025.02.015. Epub 2025 Mar 17."}]}, 'descriptionModule': {'briefSummary': 'Cosmesis postoperatively is an important consideration for both patients and surgeons and consequently surgeons have become increasingly interested in replacing conventional sutures by means of adhesive bonds for the closure of skin wounds.\n\nTherefore the investigators are using two different close techniques for laparoscopic wounds. These are; 1. sutures with steri-strips and 2. adhesive bond.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective Laparoscopic surgeries. Emergency Laparoscopic surgeries.\n\nExclusion Criteria:\n\n* Contaminated wounds. immunocompromised patients. diabetic patients. history of Keloid scarring.'}, 'identificationModule': {'nctId': 'NCT03843866', 'acronym': 'STILS', 'briefTitle': 'Sutures Versus Glue in Laparoscopic Port Site Closure.', 'organization': {'class': 'OTHER', 'fullName': "St. James's Hospital, Ireland"}, 'officialTitle': 'The Use of Absorbable Suture Versus Tissue Glue in Laparoscopic Port Skin Closure. A Prospective, Randomised Control Trial. The STILS Trial.', 'orgStudyIdInfo': {'id': 'SJH 2019-1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Suture & steri-strips', 'interventionNames': ['Other: 4-0 Monocryl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adhesive Glue', 'interventionNames': ['Other: Adhesive Glue']}], 'interventions': [{'name': '4-0 Monocryl', 'type': 'OTHER', 'otherNames': ['sutures and steri strips'], 'description': 'sutures and steri-strips', 'armGroupLabels': ['Suture & steri-strips']}, {'name': 'Adhesive Glue', 'type': 'OTHER', 'description': 'Adhesive Glue', 'armGroupLabels': ['Adhesive Glue']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dublin', 'country': 'Ireland', 'facility': 'St. James Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. James's Hospital, Ireland", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgery Specialist Registrar', 'investigatorFullName': 'Noel Edward Donlon', 'investigatorAffiliation': "St. James's Hospital, Ireland"}}}}