NCT05830006

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2022

Completed
1 year until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

Same day

First QC Date

April 22, 2022

Last Update Submit

June 17, 2024

Conditions

Cleft Lip and Nose

Keywords

microfat grafting

Outcome Measures

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.

    6 months

Secondary Outcomes (1)

  • patient and thier parents satisfaction

    6 months

Study Arms (1)

main group

EXPERIMENTAL
Procedure: Microfat grafting

Interventions

Microfat graftingPROCEDURE

Microfat grafting in cleft lip nasal deformities

main group

Eligibility Criteria

Age5 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Refusing enrollment into the study.
  • Refusing the surgery.
  • Contraindication to anaesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 28702187BACKGROUND

  • 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.

    PMID: 26194770BACKGROUND

  • 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.

    PMID: 23731585BACKGROUND

  • 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.

    PMID: 24997796BACKGROUND

  • 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.

    PMID: 24290995BACKGROUND

  • 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.

    PMID: 31048617BACKGROUND

  • 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.

    PMID: 24936094BACKGROUND

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ahmed M Ali, lecturer

    Assiut University

    STUDY CHAIR

Central Study Contacts

Susanna N Habib, bachelor

CONTACT

01279636931susa.nabil10@gmail.com

Mohamed M Thabet, Professor

CONTACT

01006667095elshazly@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Resident doctor at plastic and reconstructive surgery department at elmabbara health insurance hospital

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 26, 2023

Study Start

May 1, 2025

Primary Completion

May 1, 2025

Study Completion

October 1, 2025

Last Updated

June 18, 2024

Record last verified: 2024-06