NCT07557472

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

Nano-fat GraftingFat GraftingScar RejuvenationAutologous Fat Injection

Outcome Measures

Primary Outcomes (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.

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

Study Arms (1)

Nano-Fat Grafting

EXPERIMENTAL

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.

Procedure: Autologous Nano-Fat Grafting

Interventions

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.

Nano-Fat Grafting

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cicatrix, HypertrophicBurns

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Plastic Surgery

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 29, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04