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RecruitingNCT06566300Updated Nov 5, 2024

Autologous Nanofat Grafting by Injection Versus With Microneedling in Post-burn and Traumatic Atrophic Scars

An interventional study of injection of autologous nanofat grafting and microneedling with autologus nanofat graft in Scars, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-11-05.

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

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
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Study summary

This study aims to evaluate the efficiency autologous nanofat injection versus autologous nanofat delivered by microneedling in management of post burn atrophic and traumatic scars.

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Conditions studied

  • Scars

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In context

Atrophy

828 studies on the registry are indexed under Atrophy; 122 are open to participants now.

This study's planned enrollment of 30 is below the median of 34 across 603 interventional studies indexed under Atrophy.

Browse Atrophy studies →

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Males and females between 18-60 years old. 2. Post-burn or traumatic atrophic scar > 6 months duration (16). 3. Patients not receiving any treatments for the scar within the past 3 months.

Exclusion criteria

Exclusion Criteria:

    1. Patients with contractures, hypertrophic and keloid scars. 2. Patients with history of bleeding disorders or coagulopathy, or on anticoagulant therpy.

      1. Diabetes and other systemic diseases that may be complicated by the procedure.
      1. Pregnant and lactating females. 5. BMI less than 18.5 6. Patients with scars at the donor site
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    injection of autologous nanofat grafting

    Two separate scars with similar properties or splitting of one large post-burn atrophic scar. One (part of the) scar will be treated by injection of autologous nanofat grafting and the other (part of the) scar will be treated by microneedling with autologous nanofat graft.

    Procedure: injection of autologous nanofat grafting

  • Experimental
    microneedling with autologous nanofat graft

    Two separate scars with similar properties or splitting of one large post-burn atrophic scar. One (part of the) scar will be treated by injection of autologous nanofat grafting and the other (part of the) scar will be treated by microneedling with autologous nanofat graft.

    Procedure: microneedling with autologus nanofat graft

Interventions

  • Procedureinjection of autologous nanofat grafting

    Injection of nanfat graft

  • Proceduremicroneedling with autologus nanofat graft

    delivery of nanofat graft with microneedling

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What researchers measure

Primary outcomes

  1. change in the scar by by the patient and observer scar assessment scale (POSAS).

    patient and observer scar assessment scale score will be uesd

    Time frame: 6 months after the proceedure

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Study locations

1 of 1 sites recruiting
  • Alexandria University
    Alexandria, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Upon request and as compatible by ethical considerations

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06566300
Lead sponsor
Alexandria University
Responsible party
Dalia Ibrahim Halwag (Principal investigator, Alexandria University) — Principal investigator
First posted
Aug 22, 2024
Start date
Nov 1, 2024
Primary completion
Feb 2025 (estimated)
Completion
Feb 2025 (estimated)
Last update
Nov 5, 2024

Study contacts

Dalia I Halwag, PhD, MD
Contact
daliahalwag@gmail.com
0201224489473

Oversight

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

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