Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06566300

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

Led by Alexandria University · Updated on 2024-11-05

30

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating two ways of delivering autologous nanofat grafts to treat post-burn and traumatic atrophic scars. The study compares injections of nanofat grafts with microneedling combined with nanofat grafts to see which method better improves scar appearance. This interventional trial is sponsored by Alexandria University and focuses on adults with scars lasting more than six months. Participants will have two scars with similar properties treated differently: one scar or part of a large scar will receive nanofat graft injections, while the other scar or part will be treated with microneedling combined with nanofat grafts. Both treatments involve procedures using the patient's own nanofat tissue. The study is non-randomized and does not use masking. During the study, researchers will assess changes in the scars using the Patient and Observer Scar Assessment Scale (POSAS) six months after treatment. Participants must be adults aged 18 to 60 years with scars older than six months and not currently receiving other scar treatments. The study excludes certain types of scars and participants with specific medical conditions. The total follow-up period for outcomes is six months after the procedures.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females between 18 and 60 years old
  • Post-burn or traumatic atrophic scar older than 6 months
  • Patients not receiving any treatments for the scar within the past 3 months
Not Eligible

You will not qualify if you...

  • Patients with contractures, hypertrophic, or keloid scars
  • Patients with history of bleeding disorders, coagulopathy, or on anticoagulant therapy
  • Patients with diabetes or other systemic diseases that may complicate the procedure
  • Pregnant and lactating females
  • Body mass index less than 18.5
  • Patients with scars at the donor site

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session

Participants receive treatment on different parts of their scars by injection of autologous nanofat grafting on one part and microneedling with autologous nanofat graft on another part.

1 treatment visit (in-person)

Follow-up

Duration - 6 months

Participants are followed for assessment of scar changes up to 6 months after treatment.

Visits for follow-up assessments up to 6 months

Trial Site Locations

Total: 1 location

1

Alexandria University

Alexandria, Egypt

Actively Recruiting

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Research Team

D

Dalia I Halwag, PhD, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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