Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT02125058
Status:
COMPLETED
Last Update Posted:
2017-01-23
First Post:
2014-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracutaneous Versus Transcutaneous Sutures in the Face (IC vs TC Sutures)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-20', 'studyFirstSubmitDate': '2014-01-15', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The study aims to evaluate the cosmetic outcome 12 months post-treatment of IC compared to TC sutures after excision of a skin tumor in the face. Cosmetic result after surgery in the face', 'timeFrame': 'after 1 year', 'description': 'The study aims to evaluate the cosmetic outcome 12 months post-treatment of IC compared to TC sutures after excision of a skin tumor in the face.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intracutaneous sutures', 'transcutaneous sutures', 'dermatological surgery', 'facial area'], 'conditions': ['Skin Tumour', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Rationale:\n\nSkin cancer is common in Caucasians and often exists on sun-exposed areas, such as the face. Treatment of choice is mostly excision and result in an irreversible scar. As the incidence of skin cancer is rising, also among young people, it is important to obtain a good cosmetic outcome after treatment. It is believed that the type of closure of the wound after excision can influence the cosmetic result. Currently, primary closure of the excision can occur by transcutaneous (TC) or intracutaneous (IC) suturing. Both techniques are widely used among dermatologists and plastic surgeons and the choice is mainly dependent on the preference of the physician. Research comparing the cosmetic result of both techniques in the craniofacial area is lacking.\n\nObjective:\n\nEvaluation of the cosmetic result of transcutaneous sutures versus intracutaneous sutures in the craniofacial area.\n\nStudy design:\n\nA randomized controlled single-blinded multi-center trial.\n\nStudy population:\n\nPatients older than 18 years, with craniofacial skin tumor receiving surgery followed by primary closure at the department of Dermatology and Plastic Surgery of the Maastricht University Medical Centre, the department of Dermatology of Catharina hospital Eindhoven and the department of Plastic surgery of Orbis Medical Centre Sittard.\n\nIntervention:\n\nExcision of the tumor followed by IC sutures or TC sutures\n\nMain study endpoints:\n\nCosmetic result measured on the Patient and Observer Scar Assessment Scale (POSAS) by the patient and the researcher 12 months after surgery.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness:\n\nAll patients who participate have an indication for excision and will be assigned to one of the suture techniques. Both techniques are widely used in the regular patient care. Therefore, no extra risks are associated with it.\n\nPatients will be asked to visit the hospital 3 months and 1 year following treatment, at which point a questionnaire will be filled in and the redness of the scar will be measured by means of non-invasive techniques. In addition, patients will be asked to apply a sunscreen on the scar daily during the first three months of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients aged 18 years or older with a skin tumour of minimal 5mm in diameter in the craniofacial area requiring an excision followed by primary closure will be included. If a patient has more than one lesion, the largest lesion that can be closed primarily will be included as a maximum of one tumour per patient will be studied.\n\nExclusion Criteria:\n\n* Patients with skin lesions on the ears, nose, mucosal part of the lips or eyelids as patients suited for excision but where a transplantation, flap or secondary granulation is necessary for reconstruction of the defect will be excluded. Patients not capable of informed consent will also be excluded.'}, 'identificationModule': {'nctId': 'NCT02125058', 'briefTitle': 'Intracutaneous Versus Transcutaneous Sutures in the Face (IC vs TC Sutures)', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Randomized Controlled Trial for the Cosmetic Result of Intracutaneous Versus Transcutaneous Sutures After Dermatologic Surgery in the Face', 'orgStudyIdInfo': {'id': 'NL46056.068.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Transcutaneous sutures', 'description': 'Transcutaneous sutures', 'interventionNames': ['Procedure: Transcutaneous sutures']}, {'type': 'OTHER', 'label': 'Intracutaneous sutures', 'description': 'Intracutaneous sutures', 'interventionNames': ['Procedure: Intracutaneous sutures']}], 'interventions': [{'name': 'Transcutaneous sutures', 'type': 'PROCEDURE', 'description': 'Conventional excision followed by subcutaneous sutrues and transcutaneous sutures', 'armGroupLabels': ['Transcutaneous sutures']}, {'name': 'Intracutaneous sutures', 'type': 'PROCEDURE', 'description': 'Conventional excision followed by subcutaneous sutrues and intracutaneous sutures', 'armGroupLabels': ['Intracutaneous sutures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229HX', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Sittard', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Orbis Medical Center', 'geoPoint': {'lat': 50.99833, 'lon': 5.86944}}, {'city': 'Eindhoven', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}], 'overallOfficials': [{'name': 'Xiaomeng Liu, drs.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}