No registrations found.
ID
Source
Brief title
Health condition
Scars, scar formation, burns, burn scars, adherent scar
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pliability by the cutometer
Secondary outcome
POSAS questionnaires, both observer as patient questionnaire.
DSM colormeter
Cutometer other variables
Immunohistological stainings of biopsies.
RNA isolation out of biopsies.
Background summary
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.
Study objective
Stromal Vascular Fraction injection underneath burn scar will improve pliability of the scar more than fat grafting (historical cohort).
Study design
Preoperative, 3 months and 12 months postoperative.
Intervention
Patients will receive SVF enriched fat graft injection (ratio SVF: fat =1:10) underneath an adherent scar.
Inclusion criteria
• 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
Exclusion criteria
• 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
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8461 |
| Other | ZonMw Medische Producten Nieuw en Nodig (MPNN) : MPNN 427002011 |