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Not yet recruitingNCT05830006Updated Jun 18, 2024

Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities

An interventional study of Microfat grafting in Cleft Lip and Nose, sponsored by Assiut University. Not yet recruiting. Open to participants aged 5 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-06-18.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
5 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cleft Lip and Nose

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Keywords

  • microfat grafting
03

Who can participate

Ages eligible
5 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Refusing enrollment into the study.
  2. Refusing the surgery.
  3. Contraindication to anaesthesia.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    main group

    Procedure: Microfat grafting

Interventions

  • ProcedureMicrofat grafting

    Microfat grafting in cleft lip nasal deformities

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. patient and thier parents satisfaction

    \*Subjective assessment by evaluate patients \& their parents satisfaction from the result From zero to 4 as : Zero = not satisfied 1. = fair satisfaction 2. = good 3. = very good 4. = fully satisfied Higher scores means better

    Time frame: 6 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 28702187 ↗
  • 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. PubMed 26194770 ↗
  • 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. PubMed 23731585 ↗
  • 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. PubMed 24997796 ↗
  • 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. PubMed 24290995 ↗
  • 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. PubMed 31048617 ↗
  • 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. PubMed 24936094 ↗
08

Registry details

Key details

Study ID
NCT05830006
Lead sponsor
Assiut University
Responsible party
Susanna Nabil Habib (Principal Investigator Resident doctor at plastic and reconstructive surgery department at elmabbara health insurance hospital, Assiut University) — Principal investigator
First posted
Apr 26, 2023
Start date
May 1, 2025 (estimated)
Primary completion
May 1, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Jun 18, 2024

Study contacts

Susanna N Habib, bachelor
Contact
susa.nabil10@gmail.com
01279636931 ext. 002
Mohamed M Thabet, Professor
Contact
elshazly@aun.edu.eg
01006667095 ext. 002
Ahmed M Ali, lecturer
study chair · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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