Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities

Not Applicable

Not yet recruiting

• Conditions: Cleft Lip and Nose
• Interventions: Procedure: Microfat grafting

• Registration Number: NCT05830006
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2023-04-25
• Study First Posted: 2023-04-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Study Start: 2025-05-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
main group	Microfat grafting	-

Primary Outcome Measures

Name	Time	Method
Anthropometric measurement for the nose in relation to face	6 months	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

Name	Time	Method
patient and thier parents satisfaction	6 months	\*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