Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-01-02 @ 1:27 AM
Study NCT ID:
NCT03658603
Status:
UNKNOWN
Last Update Posted:
2018-09-05
First Post:
2018-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracodorsal Artery Perforator Flap Versus Conventional Free Flaps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-02', 'studyFirstSubmitDate': '2018-08-29', 'studyFirstSubmitQcDate': '2018-09-02', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean operative time', 'timeFrame': '12 hours', 'description': 'the time from the start to the end of operation'}], 'secondaryOutcomes': [{'measure': 'The percentage of patients with Flap viability', 'timeFrame': '1 week', 'description': 'The perforator flap will be assessed regarding (color, temperature, capillary refilling, congestion, blistering)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trauma']}, 'referencesModule': {'references': [{'pmid': '2404152', 'type': 'BACKGROUND', 'citation': 'Cannon B. The flowering of plastic surgery. JAMA. 1990 Feb 9;263(6):862-4. No abstract available.'}, {'pmid': '15923904', 'type': 'BACKGROUND', 'citation': 'Mardini S, Wei FC, Salgado CJ, Chen HC. Reconstruction of the reconstructive ladder. Plast Reconstr Surg. 2005 Jun;115(7):2174. doi: 10.1097/01.prs.0000165497.92397.be. No abstract available.'}, {'pmid': '15779080', 'type': 'BACKGROUND', 'citation': 'Lineaweaver WC. Microsurgery and the reconstructive ladder. Microsurgery. 2005;25(3):185-6. doi: 10.1002/micr.20125. No abstract available.'}, {'pmid': '12545116', 'type': 'BACKGROUND', 'citation': 'Geddes CR, Morris SF, Neligan PC. Perforator flaps: evolution, classification, and applications. Ann Plast Surg. 2003 Jan;50(1):90-9. doi: 10.1097/00000637-200301000-00016.'}, {'pmid': '15468398', 'type': 'BACKGROUND', 'citation': 'Wei FC, Mardini S. Free-style free flaps. Plast Reconstr Surg. 2004 Sep 15;114(4):910-6. doi: 10.1097/01.prs.0000133171.65075.81.'}, {'pmid': '17413879', 'type': 'BACKGROUND', 'citation': 'Hwang JH, Kim ES, Kim KS, Kim DY, Lee SY. Latissimus dorsi muscle and its short perforator-based skin compound free flap. Ann Plast Surg. 2007 Apr;58(4):381-7. doi: 10.1097/01.sap.0000243998.35882.7d.'}, {'pmid': '3737758', 'type': 'BACKGROUND', 'citation': 'Russell RC, Pribaz J, Zook EG, Leighton WD, Eriksson E, Smith CJ. Functional evaluation of latissimus dorsi donor site. Plast Reconstr Surg. 1986 Sep;78(3):336-44. doi: 10.1097/00006534-198609000-00009.'}, {'pmid': '12045540', 'type': 'BACKGROUND', 'citation': 'Wei FC, Jain V, Celik N, Chen HC, Chuang DC, Lin CH. Have we found an ideal soft-tissue flap? An experience with 672 anterolateral thigh flaps. Plast Reconstr Surg. 2002 Jun;109(7):2219-26; discussion 2227-30. doi: 10.1097/00006534-200206000-00007.'}, {'pmid': '11214052', 'type': 'BACKGROUND', 'citation': 'Kim JT, Koo BS, Kim SK. The thin latissimus dorsi perforator-based free flap for resurfacing. Plast Reconstr Surg. 2001 Feb;107(2):374-82. doi: 10.1097/00006534-200102000-00012.'}, {'pmid': '17051108', 'type': 'BACKGROUND', 'citation': 'Lin CT, Huang JS, Yang KC, Hsu KC, Chen JS, Chen LW. Reliability of anatomical landmarks for skin perforators of the thoracodorsal artery perforator flap. Plast Reconstr Surg. 2006 Nov;118(6):1376-1386. doi: 10.1097/01.prs.0000239525.44657.81.'}, {'pmid': '12560714', 'type': 'BACKGROUND', 'citation': 'Hallock GG. Direct and indirect perforator flaps: the history and the controversy. Plast Reconstr Surg. 2003 Feb;111(2):855-65; quiz 866. doi: 10.1097/01.PRS.0000040462.38363.C7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of the thoracodorsal artery perforator flap versus other conventional free flaps for reconstruction of soft tissue defects.', 'detailedDescription': 'The field of plastic surgery, unlike most other surgical specialties, has no anatomic or functional area to which it can lay claim; the plastic surgeon practices methods and techniques applicable to all specialties and anatomic areas.\n\nReconstructive surgery is the process of restoring the human body to "whole" following tumor extirpation, infection, trauma or congenital or acquired deformity - restoring both form and function.\n\nThe purpose of this study is to assess the efficacy of the thoracodorsal artery perforator flap versus other conventional free flaps for reconstruction of soft tissue defects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Soft tissue loss anywhere in the body.\n\nExclusion Criteria:\n\n• Patients with chronic debilitating diseases e.g. chronic renal failure, uncontrolled diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT03658603', 'briefTitle': 'Thoracodorsal Artery Perforator Flap Versus Conventional Free Flaps', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Thoracodorsal Artery Perforator Flap Versus Other Conventional Free Flaps in Soft Tissue Reconstruction', 'orgStudyIdInfo': {'id': 'TAPF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Thoracodorsal artery perforator flap', 'interventionNames': ['Procedure: thoracodorsal artery perforator flap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'Conventional free flaps', 'interventionNames': ['Procedure: latissimus dorsi flap']}], 'interventions': [{'name': 'thoracodorsal artery perforator flap', 'type': 'PROCEDURE', 'description': 'fascio-cutaneous flap used in cases of trauma or burns', 'armGroupLabels': ['Study group']}, {'name': 'latissimus dorsi flap', 'type': 'PROCEDURE', 'description': 'musculo-cutaneous flap used in cases of trauma or burns', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Shazly, M.D', 'role': 'CONTACT', 'email': 'elshazly@aun.edu.eg', 'phone': '01006667095', 'phoneExt': '002'}, {'name': 'Ahmed Tohamy, M.D', 'role': 'CONTACT', 'phone': '01002660832', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Sara Diefy Salem', 'investigatorAffiliation': 'Assiut University'}}}}