Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities

NCT ID: NCT05830006

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2025-10-01

Brief Summary

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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

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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.

Conditions

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Cleft Lip and Nose

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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main group

Group Type EXPERIMENTAL

Microfat grafting

Intervention Type PROCEDURE

Microfat grafting in cleft lip nasal deformities

Interventions

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Microfat grafting

Microfat grafting in cleft lip nasal deformities

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Gender : Both sex will be included in the study.
2. Postcleft lip nose deformities.

Exclusion Criteria

1. Refusing enrollment into the study.
2. Refusing the surgery.
3. Contraindication to anaesthesia.
Minimum Eligible Age

5 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Susanna Nabil Habib

Principal Investigator Resident doctor at plastic and reconstructive surgery department at elmabbara health insurance hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M Ali, lecturer

Role: STUDY_CHAIR

Assiut University

Central Contacts

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Susanna N Habib, bachelor

Role: CONTACT

01279636931 ext. 002

Mohamed M Thabet, Professor

Role: CONTACT

01006667095 ext. 002

References

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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.

Reference Type BACKGROUND
PMID: 28702187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26194770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23731585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24997796 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24290995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31048617 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24936094 (View on PubMed)

Other Identifiers

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Microfat grafting in nose

Identifier Type: -

Identifier Source: org_study_id

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