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