Cleft Lip and NoseNCT05830006
Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities
A study testing Microfat grafting in people with Cleft Lip and Nose, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 5 to 35 years
- Conditions the study is for
- Cleft Lip and Nose
- What is being tested?
- Microfat grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2027to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Gender : Both sex will be included in the study.
- Postcleft lip nose deformities.
Who cannot join
- Refusing enrollment into the study.
- Refusing the surgery.
- Contraindication to anaesthesia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Cleft Lip and Nose
- Being tested
- Microfat grafting
- Keywords
- microfat grafting
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microfat graftingProcedure or surgery
Microfat grafting in cleft lip nasal deformities
| Study group | Role | What they receive |
|---|---|---|
| main group | Experimental | Not described Receives: Procedure: Microfat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- = fair satisfaction
- = good
- = very good
- = fully satisfied Higher scores means better
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 May 2027 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and NoseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanna Nabil Habib, Assiut University
- Investigators
- Ahmed M Ali, lecturer, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830006
- Sponsor's protocol ID
- Microfat grafting in nose
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 28702187Benateau 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 26194770Jasin 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 23731585Nguyen 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 24997796Adamson 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 24290995Xu 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 31048617Cakir 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indications and Evaluation of Microfat Grafting in Cleft Lip Nasal Deformities
- ClinicalTrials.gov ID
- NCT05830006
- Acronym / sponsor ID
- Microfat grafting in nose
- Conditions
- Cleft Lip and Nose
- Keywords
- microfat grafting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2027 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| main group | Experimental | Procedure: Microfat grafting |
Who may qualify
- Ages
- 5 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Gender : Both sex will be included in the study.
- Postcleft lip nose deformities.
Key exclusion criteria (3 listed)
- Refusing enrollment into the study.
- Refusing the surgery.
- Contraindication to anaesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microfat graftingMicrofat grafting in cleft lip nasal deformities | Procedure or surgery | main group |
Primary outcome
Anthropometric measurement for the nose in relation to face
Time frame: 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.
1 secondary outcome
patient and thier parents satisfaction
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 28702187Simonacci 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.
- Background: PubMed 26194770Benateau 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.
- Background: PubMed 23731585Jasin 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.
- Background: PubMed 24997796Nguyen 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.
- Background: PubMed 24290995Adamson 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.
- Background: PubMed 31048617Xu 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.
- Background: PubMed 24936094Cakir 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed M Ali, lecturer study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Microfat grafting in people with Cleft Lip and Nose, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanna N Habib, bachelor (01279636931 ext. 002, susa.nabil10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurement for the nose in relation to face (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05830006, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.