Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-06 @ 4:26 PM
Study NCT ID:
NCT03080467
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D022125', 'term': 'Lacerations'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}], 'ancestors': [{'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 386}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-23', 'studyFirstSubmitDate': '2017-03-09', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cosmetic scar appearance', 'timeFrame': 'second follow-up visit: 6 till 12 months after wound repair', 'description': 'Cosmetic appearance will be assessed using the modified Patient and Observer Scar Measurement Score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Trauma', 'Laceration', 'Suture', 'Cosmesis', 'Ethyl-2-Cyanoacrylate', 'Tissue adhesive', 'Lip lacerations', 'Skalp lacerations', 'Facial injuries'], 'conditions': ['Tissue Adhesives', 'Laceration', 'Sutures', 'Wounds and Injuries', 'Child']}, 'referencesModule': {'references': [{'pmid': '12137689', 'type': 'BACKGROUND', 'citation': 'Farion K, Osmond MH, Hartling L, Russell K, Klassen T, Crumley E, Wiebe N. Tissue adhesives for traumatic lacerations in children and adults. Cochrane Database Syst Rev. 2002;2002(3):CD003326. doi: 10.1002/14651858.CD003326.'}, {'pmid': '9329936', 'type': 'BACKGROUND', 'citation': 'Singer AJ, Hollander JE, Quinn JV. Evaluation and management of traumatic lacerations. N Engl J Med. 1997 Oct 16;337(16):1142-8. doi: 10.1056/NEJM199710163371607. No abstract available.'}, {'pmid': '19152571', 'type': 'BACKGROUND', 'citation': 'Idriss N, Maibach HI. Scar assessment scales: a dermatologic overview. Skin Res Technol. 2009 Feb;15(1):1-5. doi: 10.1111/j.1600-0846.2008.00327.x.'}, {'pmid': '20596233', 'type': 'BACKGROUND', 'citation': 'Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.'}, {'pmid': '21200219', 'type': 'BACKGROUND', 'citation': 'Fearmonti RM, Bond JE, Erdmann D, Levin LS, Pizzo SV, Levinson H. The modified Patient and Observer Scar Assessment Scale: a novel approach to defining pathologic and nonpathologic scarring. Plast Reconstr Surg. 2011 Jan;127(1):242-247. doi: 10.1097/PRS.0b013e3181f959e8.'}, {'pmid': '19501559', 'type': 'BACKGROUND', 'citation': 'Brown BC, Moss TP, McGrouther DA, Bayat A. Skin scar preconceptions must be challenged: importance of self-perception in skin scarring. J Plast Reconstr Aesthet Surg. 2010 Jun;63(6):1022-9. doi: 10.1016/j.bjps.2009.03.019. Epub 2009 Jun 5.'}, {'pmid': '7662573', 'type': 'BACKGROUND', 'citation': "Lewis-Jones MS, Finlay AY. The Children's Dermatology Life Quality Index (CDLQI): initial validation and practical use. Br J Dermatol. 1995 Jun;132(6):942-9. doi: 10.1111/j.1365-2133.1995.tb16953.x."}, {'pmid': '26686685', 'type': 'BACKGROUND', 'citation': "Olsen JR, Gallacher J, Finlay AY, Piguet V, Francis NA. Quality of life impact of childhood skin conditions measured using the Children's Dermatology Life Quality Index (CDLQI): a meta-analysis. Br J Dermatol. 2016 Apr;174(4):853-61. doi: 10.1111/bjd.14361. Epub 2016 Mar 6."}, {'pmid': '33643965', 'type': 'DERIVED', 'citation': 'Fontana S, Schiestl CM, Landolt MA, Staubli G, von Salis S, Neuhaus K, Mohr C, Elrod J. A Prospective Controlled Study on Long-Term Outcomes of Facial Lacerations in Children. Front Pediatr. 2021 Feb 12;8:616151. doi: 10.3389/fped.2020.616151. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This project is an observational trial investigating wound cosmetic appearance after repair of traumatic skin lacerations in the head area of pediatric patients with two different approaches to skin closure: sutures versus tissue adhesive. Photographs will be taken at two follow-up visits after repair and later assessed by external blinded plastic surgeon using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in these two wound repair treatment options.', 'detailedDescription': "Investigation of the long-term outcome of 300 pediatric patients with traumatic skin lacerations in the head area. After primary wound repair with suture or with tissue adhesive, eligible patients will be enrolled on the emergency department (baseline visit). The second follow-up visit will take place 5-10 days after the baseline visit and the third follow-up visit will be completed 6-12 months after trauma. At both follow-up visits, clinical examination and a brief interview will be performed. Photo documentation is completed at both the baseline and the follow-up visit.\n\nEncrypted photo documentation will be evaluated by blinded external plastic surgeons. Primary Outcome is the cosmetic appearance using standard assessment scales, secondary outcomes are the occurrence of complications, cost-effectiveness and patient's satisfaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients after completion of a primary wound repair treatment with suture or tissue adhesive in the Pediatric Emergency Unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 0 till16 years of age\n* Any primary wound repair treatment of a laceration caused by trauma and involving the skin of the head area\n* Patient or caregiver must be able to understand and sign an informed consent\n\nExclusion Criteria:\n\n* Pre-existing conditions that affect wound healing adversely\n* Patients who demonstrate severe or life-threatening injuries\n* Patients / caregivers with communication / logistic barriers that would make them unfit to provide informed consent or to attend the follow-up visits'}, 'identificationModule': {'nctId': 'NCT03080467', 'briefTitle': 'Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital, Zurich"}, 'officialTitle': 'Long-term Outcome of the Primary Wound Repair of Traumatic Skin Lacerations in the Head Area in Pediatric Patients: Suture Versus Tissue Adhesive', 'orgStudyIdInfo': {'id': '2016-01304'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suture', 'description': 'Wound repair with suture'}, {'label': 'Tissue adhesive', 'description': 'Wound repair with tissue adhesive'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': "Children's University Hospital of Zurich", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Clemens M Schiestl, PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's University Hospital of Zurich"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital, Zurich", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}