Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-31 @ 1:27 PM
Study NCT ID:
NCT05830006
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2022-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2022-04-22', 'studyFirstSubmitQcDate': '2023-04-25', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anthropometric measurement for the nose in relation to face', 'timeFrame': '6 months', 'description': 'Results would be depending on objective and subjective measures :\n\n\\*Objective assessment by taking photos by anthropometric measurement for the nose in relation to face.'}], 'secondaryOutcomes': [{'measure': 'patient and thier parents satisfaction', 'timeFrame': '6 months', 'description': '\\*Subjective assessment by evaluate patients \\& their parents satisfaction from the result\n\nFrom zero to 4 as :\n\nZero = not satisfied\n\n1. = fair satisfaction\n2. = good\n3. = very good\n4. = fully satisfied Higher scores means better'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microfat grafting'], 'conditions': ['Cleft Lip and Nose']}, 'referencesModule': {'references': [{'pmid': '28702187', 'type': 'BACKGROUND', 'citation': 'Simonacci F, Bertozzi N, Grieco MP, Grignaffini E, Raposio E. Procedure, applications, and outcomes of autologous fat grafting. Ann Med Surg (Lond). 2017 Jun 27;20:49-60. doi: 10.1016/j.amsu.2017.06.059. eCollection 2017 Aug.'}, {'pmid': '26194770', 'type': 'BACKGROUND', 'citation': 'Benateau H, Rocha CS, Rocha Fde S, Veyssiere A. Treatment of the nasal abnormalities of Hallermann-Streiff syndrome by lipofilling. Int J Oral Maxillofac Surg. 2015 Oct;44(10):1246-9. doi: 10.1016/j.ijom.2015.06.020. Epub 2015 Jul 17.'}, {'pmid': '23731585', 'type': 'BACKGROUND', 'citation': 'Jasin ME. Nonsurgical rhinoplasty using dermal fillers. Facial Plast Surg Clin North Am. 2013 May;21(2):241-52. doi: 10.1016/j.fsc.2013.02.004.'}, {'pmid': '24997796', 'type': 'BACKGROUND', 'citation': 'Nguyen PS, Baptista C, Casanova D, Bardot J, Magalon G. [Autologous fat grafting and rhinoplasty]. Ann Chir Plast Esthet. 2014 Dec;59(6):548-54. doi: 10.1016/j.anplas.2014.05.006. Epub 2014 Jul 3. French.'}, {'pmid': '24290995', 'type': 'BACKGROUND', 'citation': 'Adamson PA, Warner J, Becker D, Romo TJ 3rd, Toriumi DM. Revision rhinoplasty: panel discussion, controversies, and techniques. Facial Plast Surg Clin North Am. 2014 Feb;22(1):57-96. doi: 10.1016/j.fsc.2013.09.002.'}, {'pmid': '31048617', 'type': 'BACKGROUND', 'citation': 'Xu J, Jiang B, Shen Y. Effectiveness of Autologous Fat Grafting in Scaring After Augmentation Rhinoplasty. J Craniofac Surg. 2019 May/Jun;30(3):914-917. doi: 10.1097/SCS.0000000000005248.'}, {'pmid': '24936094', 'type': 'BACKGROUND', 'citation': 'Cakir B, Oreroglu AR, Daniel RK. Surface Aesthetics in Tip Rhinoplasty: A Step-by-Step Guide. Aesthet Surg J. 2014 Aug;34(6):941-55. doi: 10.1177/1090820X14537643. Epub 2014 Aug 1.'}]}, 'descriptionModule': {'briefSummary': "Aim of the work:\n\nThe study will be conducted to investigate the efficacy of microfat graftinig in cleft lip nasal deformities especially in young patients and those adults who don't need major correction after rhinoplasty.", 'detailedDescription': "Microfat grafting was used for the first time in 1880, in reconstructive surgery to correct facial deformities, to reconstruct defects post oncological surgery, to treat complex wounds, and to manage scars. Therefore its usage is increasing widely and particularly in maxillofacial and plastic surgeries.\n\nAs lipofilling is a potential filler of reference for rhinoplasty and it can be performed on the dorsum, radix, glabella, pre-maxilla, and nasal pyramid. The investigators are suggesting it's use in cleft lip nasal deformities in some special situations.\n\nImperfections post rhinoplasty are common and there is an increased risk of patient dissatisfaction in revision surgeries. This may be due to a change in the nasal anatomy, the development of scar tissue, the loss of cartilaginous support, the altered blood supply, and the compromised soft tissue envelope. Here comes the role of fat grafting which is a relatively simple and safe procedure to camouflage nose imperfections in filling the subcutaneous tissue, and in improving the skin quality post rhinoplasty.\n\nMicrofat grafting appears to be effective for correcting minor irregularities of nasal skin and may be appropriate for patients who cannot undergo revision rhinoplasty. It is also an effective salvage procedure for severely damaged skin of the nose. Injection of cryopreserved fat over several sessions is well accepted by patients because cryopreservation of excess harvested fat grafts for subsequent use makes repeated fat graft harvesting unnecessary. Microfat grafting is not a replacement for, but may be a complement to, modern rhinoplasty techniques."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Gender : Both sex will be included in the study.\n2. Postcleft lip nose deformities.\n\nExclusion Criteria:\n\n1. Refusing enrollment into the study.\n2. Refusing the surgery.\n3. Contraindication to anaesthesia.'}, 'identificationModule': {'nctId': 'NCT05830006', 'briefTitle': 'Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities', 'orgStudyIdInfo': {'id': 'Microfat grafting in nose'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'main group', 'interventionNames': ['Procedure: Microfat grafting']}], 'interventions': [{'name': 'Microfat grafting', 'type': 'PROCEDURE', 'description': 'Microfat grafting in cleft lip nasal deformities', 'armGroupLabels': ['main group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Susanna N Habib, bachelor', 'role': 'CONTACT', 'email': 'susa.nabil10@gmail.com', 'phone': '01279636931', 'phoneExt': '002'}, {'name': 'Mohamed M Thabet, Professor', 'role': 'CONTACT', 'email': 'elshazly@aun.edu.eg', 'phone': '01006667095', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Ahmed M Ali, lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Resident doctor at plastic and reconstructive surgery department at elmabbara health insurance hospital', 'investigatorFullName': 'Susanna Nabil Habib', 'investigatorAffiliation': 'Assiut University'}}}}