Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-28 @ 5:57 AM
Study NCT ID:
NCT06103461
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fat Grafting an Ideal Filler For Contour Deformities With Hyperpigmentation On Face
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017495', 'term': 'Hyperpigmentation'}], 'ancestors': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Cohort study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2023-10-21', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IDC', 'timeFrame': '6 Months', 'description': 'integrated color density'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pigmentation', 'Contour defect', 'Fat grafting'], 'conditions': ['Hyperpigmentation']}, 'descriptionModule': {'briefSummary': 'Pigmentary changes are commonly associated with contour defects of facial region. These deformities cause cosmetic concerns. Traditionally used techniques indwelling limitations and therefore it invokes innovative techniques to treat contour abrasion and pigmentation simultaneously. The current study focuses on evaluation of the role of autologous fat in improving contour defects of face associated with hyperpigmentation. 100 subjects having contour defects related skin pigmentation were recruited from Feb 2022 till Feb 2023. Fat was harvested, processed under sterilized conditions and grafted into the affected regions of face. The patients were kept under follow up for one year after fat injection. Subjective as well as objective evaluation was done before treatment and one year after fat injection. Results showed significant improvement in pigmentation after fat injection. Most of the patients had high satisfaction regarding improvement in pigmentation and pliability of the grafted area after use of fat graft. A software Image J was applied to objectively showing changes in hyperpigmentation of face after fat graft. In conclusion, utility of autologous fat has effective and promising role as an ideal filler for treating contour defects of face with pigmentary changes', 'detailedDescription': "Introduction Facial contour defects need augmentation have pigmentary issues related to them. Such defects are noticed after trauma, autoimmune disease or after infection. These combined contour and pigmentary defects cause social as well as aesthetic concerns. Discolored skin makes them more prominent. Conventionally, fillers are employed but these are short lived at one hand while do not treat pigmentation on the other hand. Body tissues in the form of flaps have also been tried but with the same outcome as with the fillers. Lasers and chemical depigmentation improve skin color but has to do nothing with filling of the contour. In short so far, no single satisfactory remedy is available for such issues. Therefore, some innovative strategy is needed which can fill contour defect and resolves pigmentation too.\n\nAdipose tissue, being autologous, is a pronounced source with regenerative potential as well as natural augmentation. Due to its abundance, easy harvesting and pliability at recipient site make it ideal. Filling effect is just one aspect rather grafted fat not only softens scars, rejuvenates skin but also improves pigmentation. Therefore, in our study we aimed at the evaluation of fat as an ideal filler.\n\nMaterials and Methods This prospective study was conducted in Plastic \\& Reconstructive Surgery Department of KEMU Lahore from Feb 2022 to Feb 2023. Hundred patients of both genders and age between 10 to 50 years having contour defects on face were recruited.\n\nPatients having rejuvenation procedure like filler, laser, depigmentation or PRP done were excluded from the study. Biodata along with deformity details were noted. Advantages, limitations and likely complications related to the procedure were explained and informed consent was documented.\n\nPre-procedure skin texture, color and defect was noted. Donor area was marked and local anesthesia with 0.5% Xylocain and 1:500,000 Adrenaline in normal saline was infiltrated with one milliliter of fluid for one milliliter of fat to be procured. Fat was procured with blunt 2-mm multi-hole cannula using 10cc Luer-Lok syringe under manual suction applied not more than 2ml. Then fat was transferred to recipient area by using Icc syringe and infiltration canula till symmetry achieved with contralateral respective area of face. Grafted area photographed and integrated color density (ICD1) was found with ImageJ. All patients were observed for 24 hours to look for any complication. Oral analgesic and antibiotics were prescribed for 3 days. Patients were kept under monthly follow up and sessions were repeated if required (13). Subjective as well as objective measurement of outcomes was done. For objective evaluation, repeat photograph was taken after one year of deformity got resolved. Integrated color density (ICD2) was again measured and compared with ICD1. For subjective evaluation, patient's was noted.\n\nFindings were recorded and variables like age, gender, area involved, duration, ICD and satisfaction documented. SPSS 22 used for data analysis with p- Value \\<0.05 considered significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pigmentation with contour defect\n\nExclusion Criteria:\n\n* Unfit for anesthesia'}, 'identificationModule': {'nctId': 'NCT06103461', 'briefTitle': 'Fat Grafting an Ideal Filler For Contour Deformities With Hyperpigmentation On Face', 'organization': {'class': 'OTHER', 'fullName': 'King Edward Medical University'}, 'officialTitle': 'Fat Grafting an Ideal Filler For Contour Deformities With Hyperpigmentation On Face', 'orgStudyIdInfo': {'id': 'kemu/23/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fat Grafting', 'description': 'It is an experimental study for effect of fat grafting on pigmentation of skin', 'interventionNames': ['Procedure: Autologous fat grafting']}], 'interventions': [{'name': 'Autologous fat grafting', 'type': 'PROCEDURE', 'description': 'Autologous fat grafted at contour defects with pigmentary changes', 'armGroupLabels': ['Fat Grafting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'King Edward Medical University', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Afzaal Bashir, FACS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Edward Medical University, Lahore, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Statistical data to be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Edward Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Afzaal Bajwa', 'investigatorAffiliation': 'King Edward Medical University'}}}}