Stromal Vascular Fraction injection underneath burn scar will improve pliability of the scar more than fat grafting (historical cohort).
ID
Bron
Verkorte titel
Aandoening
Scars, scar formation, burns, burn scars, adherent scar
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Pliability by the cutometer
Achtergrond van het onderzoek
Fat grafting is recognized as a promising and novel technique in the treatment of adherent scars. This is strongly supported by evidence-based clinical trials as well as fundamental studies in animals and in vitro. Recently, acquiring Stromal Vascular Fraction (SVF), containing adipocyte stromal cells (ADSCs), out of lipoaspirate became easier with a fast-non-enzymatic intra-operative procedure. ADSCs increase angiogenesis, can induce mitosis in resident tissue cells and are able to remodel collagen. The hypothesis is that SVF can therefore be beneficial in the treatment of adherent scars. In previous adherent scar research, it’s also stated that the enrichment of fat grafts with ADSCs should be explored.
To investigate the potential beneficial effect of SVF on scars, we set up a collaboration between the two Dutch Burn Centres, ‘Red Cross Hospital Beverwijk’ and ‘Martini Hospital Groningen’, and the Tissue Engineering department (Medical Biology) of the University and Medical Centre Groningen (UMCG).
Our aim in this study is to investigate the potential beneficial effect of SVF enriched fat grafting (combination therapy), containing ADSCs, on pliability of adherent scars, compared with fat grafting, the current standard of care.
Doel van het onderzoek
Stromal Vascular Fraction injection underneath burn scar will improve pliability of the scar more than fat grafting (historical cohort).
Onderzoeksopzet
Preoperative, 3 months and 12 months postoperative.
Onderzoeksproduct en/of interventie
Patients will receive SVF enriched fat graft injection (ratio SVF: fat =1:10) underneath an adherent scar.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Patients seen by a plastic surgeon in Burn Centre Beverwijk or Groningen
• Patient is ≥ 18 years old
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Previous scar treatment with fat grafting in selected scar
• General exclusion criteria for fat grafting procedure: pregnancy, BMI < 18
• Skin melanoma in patient’s history
• Unwillingness to commit to the study protocol and show up for all follow up moments
• Insufficient proficiency in Dutch to the extent that clear communication is not possible
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8461 |
| Ander register | ZonMw Medische Producten Nieuw en Nodig (MPNN) : MPNN 427002011 |