- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07557472
Nano-Fat Grafting for Post-Burn Scars on the Chest, Shoulders, and Back
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nano-Fat Grafting
Participants 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Vancouver Scar Scale (VSS) Total Score
Time Frame: Baseline, 1 month, 3 months, and 6 months post-operatively.
|
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.
|
Baseline, 1 month, 3 months, and 6 months post-operatively.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nano-Fat in Torso Burn Scars
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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