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Hypertrophic ScarsNCT07557472

Nano-Fat Grafting for Post-Burn Scars on the Chest, Shoulders, and Back

A study testing Autologous Nano-Fat Grafting in people with Hypertrophic Scars and Post-burn Scars, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study aims to evaluate the effectiveness of nano-fat grafting in treating hypertrophic scars caused by burns on the chest, shoulders, and back. Burn scars in these specific areas are often difficult to treat because the skin is under constant tension and motion, which can prolong inflammation and worsen the scar. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Hypertrophic Scars, Post-burn Scars, Burns
What is being tested?
Autologous Nano-Fat Grafting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
No sites listed yet
Study dates
Jun 2026to Jul 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 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18 to 50 years.
  • Presence of post-burn hypertrophic scars located on the chest, shoulders, or back.
  • Age of the scar is less than 6 months.

Who cannot join

  • Active infection or ulceration at the site of the scar.
  • Patients with systemic connective tissue diseases or bleeding disorders.
  • Hypertrophic scars older than 6 months.
  • History of keloids or previous surgical excision of the same scar.
  • Previous corticosteroid injections into the scar.
  • Pregnancy and lactation.
  • Refusal to undergo surgery.

About this study

Official title: Evaluation of Nano-Fat Grafting in Post-Burn Hypertrophic Scars at Chest, Shoulders, and Back

This study aims to evaluate the effectiveness of nano-fat grafting in treating hypertrophic scars caused by burns on the chest, shoulders, and back.

Burn scars in these specific areas are often difficult to treat because the skin is under constant tension and motion, which can prolong inflammation and worsen the scar. While conventional scar treatments like silicone patches, pressure garments, and steroid injections are widely used, they do not always completely restore normal tissue. Nano-fat grafting is emerging as a promising regenerative option. This procedure involves taking a small amount of the patient's own fat and processing it into a liquid that is rich in healing cells. This liquid is then injected directly into the scar to potentially improve skin texture, color, and flexibility.

Read more

The study will enroll 55 participants between the ages of 18 and 50. To be eligible, patients must have a post-burn hypertrophic scar on their chest, shoulder, or back that is less than 6 months old.

During the study, doctors will harvest a small amount of fat from the patient's abdomen or thighs using a small tube. This fat will be carefully washed, processed, and passed through a special filter to create liquid nano-fat. The liquid is then gently injected into the scar tissue.

Researchers will monitor the patients and evaluate the scars at 1, 3, and 6 months after the injection. They will use standard clinical scar assessments (the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale) alongside photographs to measure improvements in scar color, thickness, pliability, and overall appearance, as well as patient-reported symptoms like pain and itching.

Read the detailed description

Hypertrophic scar formation following burn injuries is a complex process driven by excessive collagen deposition, prolonged wound healing, and altered tissue remodeling. Post-burn hypertrophic scars located on the chest, shoulders, and back present a particularly significant clinical challenge. Because these anatomical regions are subjected to constant tension, stretching, and motion, the healing scar is repeatedly stressed, which can prolong inflammation and exacerbate scar thickness and stiffness. This persistent hypertrophy often leads to functional limitations, cosmetic disfigurement, severe discomfort, and psychological distress. While conventional scar therapies, such as silicone applications, pressure garments, corticosteroid injections, and laser treatments, are widely utilized, they do not reliably restore normal tissue architecture for all patients, particularly in these high-tension areas.

To address these limitations, autologous nanofat grafting has emerged as a promising regenerative biologic therapy. Unlike traditional structural fat grafting used primarily to fill tissue voids, mechanically processed nanofat is rich in stromal and cellular components that act to modulate local inflammation, support angiogenesis, and improve extracellular matrix remodeling. Recent histological, imaging, and clinical studies indicate that nanofat treatment can yield statistically significant improvements in scar pigmentation, pliability, vascularity, and height, while also reducing patient-reported symptoms like pain and itching.

The primary aim of this prospective study is to evaluate the safety and efficacy of intradermal nanofat injections for the management of post-burn hypertrophic scars specifically on the chest, shoulders, and back. By targeting these difficult and highly mobile anatomical regions, this research seeks to add focused clinical evidence to the existing literature using standardized scar assessment outcomes.

The study will be conducted at the Plastic Surgery Departments of Assiut University Hospital and Elmabarra Health Insurance Hospital. Enrolled participants will undergo a minimally invasive procedure where adipose tissue is harvested from the abdomen or thighs using low-pressure liposuction or a manual vacuum syringe. The harvested fat is washed with saline and mechanically emulsified by passing it between two 10cc syringes for 30 passes. It is then pushed through a nano-filter to isolate the liquid nanofat. This regenerative product is subsequently injected intradermally directly into the hypertrophic scar using a fine needle (27G or 30G) until slight blanching of the tissue is observed.

To evaluate the intervention, patients will undergo clinical assessments at baseline and during postoperative follow-up visits at 1, 3, and 6 months. The primary clinical evaluation tool will be the Vancouver Scar Scale (VSS), which quantifies changes in scar color, pigmentation, pliability, and height. Additionally, the Patient and Observer Scar Assessment Scale (POSAS) will be utilized to capture both the surgeon's objective evaluation (including vascularity, thickness, and surface area) and the patient's subjective experience (including pain, itching, and stiffness). Aesthetic outcomes and skin texture changes will be further analyzed using standardized photographic documentation, maintaining fixed lighting, backgrounds, and camera angles for all pre- and post-operative images. Participants will be continuously monitored for any potential complications associated with fat grafting, such as persistent erythema, hematoma, or infection.

Being tested
Autologous Nano-Fat Grafting
Keywords
Nano-fat Grafting, Fat Grafting, Scar Rejuvenation, Autologous Fat Injection
Medical subject headings
Cicatrix, Hypertrophic, Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Nano-Fat GraftingProcedure or surgery

    Fat is harvested from the patient's abdomen or thighs via a 3-mm cannula. It is then washed with saline, emulsified by shifting it between two 10cc syringes for 30 passes, and passed through a nano-filter to create liquid nano-fat. This autologous product is injected intradermally directly into the scar using a 27G or 30G needle until slight blanching occurs.

Study groups in NCT07557472
Study groupRoleWhat they receive
Nano-Fat GraftingExperimentalParticipants in this arm will receive an intradermal injection of autologous liquid nano-fat directly into their post-burn hypertrophic scars. Fat is harvested from the patient's abdomen or thighs, mechanically emulsified, and passed through a nano-filter. The resulting liquid nano-fat is then injected into the scar tissue using a 27G or 30G needle until slight blanching is observed.
Receives: Procedure: Autologous Nano-Fat Grafting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Vancouver Scar Scale (VSS) Total Score

    The Vancouver Scar Scale (VSS) is a standard clinical assessment tool used to evaluate scar quality. It assesses four parameters: pigmentation (scored 0-2), vascularity/color (scored 0-3), pliability (scored 0-5), and height (scored 0-3). The individual scores from these four parameters are summed to yield a total score ranging from 0 to 13. A total score of 0 represents normal, healthy skin, whereas a higher score (up to a maximum of 13) indicates a more severe, pathological hypertrophic scar.

    Measured: Baseline, 1 month, 3 months, and 6 months post-operatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07557472
Sponsor's protocol ID
Nano-Fat in Torso Burn Scars
Status last verified
Apr 2026
First submitted
23 Apr 2026
Last updated
29 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Autologous Nano-Fat Grafting in people with Hypertrophic Scars and Post-burn Scars, 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 3 inclusion and 7 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 Apr 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Vancouver Scar Scale (VSS) Total Score (time frame: Baseline, 1 month, 3 months, and 6 months post-operatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Apr 2026.

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