Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities

Cleft Lip and Nose Clinical Trial

Official title:

Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05830006
• Other study ID #: Microfat grafting in nose
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2025
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2024
• Source: Assiut University
• Contact: Susanna N Habib, bachelor
• Phone: 01279636931
• Email: susa.nabil10[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Nose

Intervention

Procedure:
• Microfat grafting
Microfat grafting in cleft lip nasal deformities

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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	6 months