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Stromal Vascular Fraction injectable as treatment of adherent burn scars.

Stromal Vascular Fraction injectable as treatment of adherent burn scars. - SVF injectable as treatment of burn scars.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49720
Enrollment
46
Registered
2020-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn scars fibrosis hypertrophic skin

Interventions

Patients will receive SVF enriched fat graft injection (ratio SVF: fat =1:10) underneath an adherent scar.

Sponsors

Rode Kruis Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients seen by the plastic surgeon in Burn Centre Beverwijk or Groningen with adherent scars caused by burns, necrotic fasciitis or degloving injury with no history of prior surgical treatment of the scar, other than skin transplantation. - Minimum age of 18 - Patient has an adherent scar (minimum scar age: 12 months) caused by burns, necrotic fasciitis or degloving injury, for which fat grafting is indicated - Competent adults

Exclusion criteria

Exclusion criteria: - Previous scar treatment with fat grafting in selected scar - General exclusion criteria for fat grafting procedure: pregnancy, BMI

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter is change in scar pliability, measured by the Cutometer Skin Elasticity Meter 575 (Courage and Khazaka GmbH, Cologne, Germany) between pre- and 12 months post grafting.

Secondary

MeasureTime frame
Change in scar pliability, retraction, elasticity, viscoelasticity and maximum extension between pre- and 3 months and 3- and 12 months post SVF enriched grafting will be analysed. Change in retraction, elasticity, viscoelasticity and maximum extension will also be analysed between pre- and 12 months post grafting. Change in the quantity of melanin and erythema will be measured with the DSM II ColorMeter (Cortex Technology, Hadsund, Denmark) immediately before (i.e. within 24 hours before treatment) and at 3 and 12 months post grafting. Change in quantity of melanin and erythema will be analysed between pre- and 3 months post grafting and between 3 months and 12 months post grafting. Change in scar quality will be measured with the Patient and Observer Scar Assessment Scale (POSAS), immediately before (i.e. within 24 hours before treatment) and at 3 and 12 months post grafting. Changes in the POSAS Patient and Observer scale will be analysed between pre- and 3 months post grafting and between 3 months and 12 months post grafting. Histological changes of the scar are objectified by taking 2 mm biopsies of the dermal fat on fixed positions, just before treatment and at 12 months follow up. For patients to participate in our research, this histological part is optional. Histological observation will focus on extracellular matrix remodelling, epidermis renewal, cell infiltration and new microvasculature formation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)