Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-30 @ 3:54 AM
Study NCT ID:
NCT04238468
Status:
UNKNOWN
Last Update Posted:
2020-03-24
First Post:
2020-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scar Tissue Analysis After Intraoperative Application of Stromal Vascular Fraction Cells Into Suture Line
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patient, investigator, outcome assessor will be blinded for which side of the scar was injected with stromal vascular fraction. Only the surgeon will know which site was injected.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-23', 'studyFirstSubmitDate': '2020-01-18', 'studyFirstSubmitQcDate': '2020-01-18', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of stromal vascular fraction by flow cytometry', 'timeFrame': '2 hours', 'description': 'Cell viability and cell type specification of stromal vascular fraction will be evaluated by flow cytometry.'}, {'measure': 'Histological analysis of epidermal thickness of scar tissue', 'timeFrame': '10 months', 'description': 'Epidermal thickens of scar tissue on the injected and control site will be compared.'}, {'measure': 'Histological analysis of rete ridges of scar tissue', 'timeFrame': '10 months', 'description': 'Number of rete ridges of scar tissue on the injected and control site will be compared.'}, {'measure': 'Histological quantification of elastin of scar tissue.', 'timeFrame': '10 months', 'description': 'Quantification of elastin of scar tissue will be compared on the injected and control site.'}, {'measure': 'Histological quantification of vascularity in scar tissue', 'timeFrame': '10 months', 'description': 'Vascularity will be histologically quantified and compared on the injected and control site.'}, {'measure': 'Histological quantification of inflammatory cells in scar tissue', 'timeFrame': '10 months', 'description': 'Inflammatory cells will be histologically quantified and compared on the injected and control site.'}, {'measure': 'Clinical outcome by the use of Patient and Observer Scar Assessment Scale (POSAS)', 'timeFrame': '10 months', 'description': "Scar will be evaluated by the Patient and Observer Scar Assessment Scale. The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically and make up a 'Total Score' of the Patient and Observer Scale. The sum altogether will give the 'Total Score' of the POSAS. Besides the 10-step scale, category boxes are available to score nominal parameters (e.g. type of colour). Moreover, the patient and observer also score their 'Overall Opinion'."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wound Heal', 'Scar', 'Hypertrophic Scar', 'Delayed Wound Healing']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the effect of intradermal injection of stromal vascular fraction into suture line on wound healing and scarring.', 'detailedDescription': 'Patients undergoing primary or secondary Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction will be included in this monocentric, randomised, controlled, double-blinded study.\n\nAfter bilateral flank liposuction, the fat will be processed by a special protocol with enzymatic digestion. Stromal vascular fraction will be isolated and injected intradermally just after wound closure into one site of surgical wound (most lateral 5 cm) at the DIEP flap donor site. The other site of DIEP flap donor site (most lateral 5 cm) will serve as a control. Part of stromal vascular fraction will be analysed by flow cytometry for the viability and cell specification. Ten months after DIEP flap surgery the scars at both sites (control and injected site) will be excised and analysed histologically. At that time photographs will be taken and scars will be analysed by Patient and Observer Assesment Scale (POSAS).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* breast cancer patients scheduled for primary or secondary DIEP flap breast reconstruction\n\nExclusion Criteria:\n\n* BMI\n* age\n* immunosuppressive disease'}, 'identificationModule': {'nctId': 'NCT04238468', 'briefTitle': 'Scar Tissue Analysis After Intraoperative Application of Stromal Vascular Fraction Cells Into Suture Line', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Scar Tissue Analysis After Intraoperative Intradermal Application of Stromal Vascular Fraction Cells Into Suture Line', 'orgStudyIdInfo': {'id': 'SSVF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intradermal injection of stromal vascular fraction', 'description': 'Most lateral 5 cm of abdominal donor site will be injected with stromal vascular fraction just after the wound is closed.', 'interventionNames': ['Procedure: Intradermal stromal vascular fraction injection']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'Most contralateral 5 cm of abdominal donor site will serve as control.'}], 'interventions': [{'name': 'Intradermal stromal vascular fraction injection', 'type': 'PROCEDURE', 'description': 'After flank liposuction, lipoaspirate will be processed by enzymatic digestion, thus stromal vascular fraction will be isolated. Just after the wound is closed the stromal vascular fraction diluted in normal saline (5ml) will be injected intradermally on one site.', 'armGroupLabels': ['Intradermal injection of stromal vascular fraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Katarina Zivec', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Centre Ljubljana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Katarina Zivec', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Katarina Zivec', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}