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Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities

Primary Purpose

Cleft Lip and Nose

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Microfat grafting
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip and Nose focused on measuring microfat grafting

Eligibility Criteria

5 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Gender : Both sex will be included in the study. Postcleft lip nose deformities. Exclusion Criteria: Refusing enrollment into the study. Refusing the surgery. Contraindication to anaesthesia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    main group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Anthropometric measurement for the nose in relation to face
    Results would be depending on objective and subjective measures : *Objective assessment by taking photos by anthropometric measurement for the nose in relation to face.

    Secondary Outcome Measures

    patient and thier parents satisfaction
    *Subjective assessment by evaluate patients & their parents satisfaction from the result From zero to 4 as : Zero = not satisfied = fair satisfaction = good = very good = fully satisfied Higher scores means better

    Full Information

    First Posted
    April 22, 2022
    Last Updated
    April 25, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05830006
    Brief Title
    Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities
    Official Title
    Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2023 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Aim of the work: The 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.
    Detailed Description
    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. As 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. Imperfections 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. Microfat 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cleft Lip and Nose
    Keywords
    microfat grafting

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    main group
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Microfat grafting
    Intervention Description
    Microfat grafting in cleft lip nasal deformities
    Primary Outcome Measure Information:
    Title
    Anthropometric measurement for the nose in relation to face
    Description
    Results would be depending on objective and subjective measures : *Objective assessment by taking photos by anthropometric measurement for the nose in relation to face.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    patient and thier parents satisfaction
    Description
    *Subjective assessment by evaluate patients & their parents satisfaction from the result From zero to 4 as : Zero = not satisfied = fair satisfaction = good = very good = fully satisfied Higher scores means better
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Gender : Both sex will be included in the study. Postcleft lip nose deformities. Exclusion Criteria: Refusing enrollment into the study. Refusing the surgery. Contraindication to anaesthesia.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Susanna N Habib, bachelor
    Phone
    01279636931
    Ext
    002
    Email
    susa.nabil10@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed M Thabet, Professor
    Phone
    01006667095
    Ext
    002
    Email
    elshazly@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed M Ali, lecturer
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28702187
    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.
    Results Reference
    background
    PubMed Identifier
    26194770
    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.
    Results Reference
    background
    PubMed Identifier
    23731585
    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.
    Results Reference
    background
    PubMed Identifier
    24997796
    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.
    Results Reference
    background
    PubMed Identifier
    24290995
    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.
    Results Reference
    background
    PubMed Identifier
    31048617
    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.
    Results Reference
    background
    PubMed Identifier
    24936094
    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.
    Results Reference
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    Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities

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