To assess the change in scar pliability measured by the Cutometer (primary outcome) pre- and 12 months post grafting and to quantify clinical and histological improvements of scar characteristics with the combination therapy of SVF enriched fat…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Fat grafting is regarded 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 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.
Study objective
To assess the change in scar pliability measured by the Cutometer (primary
outcome) pre- and 12 months post grafting and to quantify clinical and
histological improvements of scar characteristics with the combination therapy
of SVF enriched fat grafts.
Study design
Prospective longitudinal multi-centre cohort study.
Intervention
Patients will receive SVF enriched fat graft injection (ratio SVF: fat =1:10)
underneath an adherent scar.
Study burden and risks
All measurement moments will take around 30 minutes. The pre-op measurements
are combined with the surgical procedure and the 3 months post-op measurement
is combined with a regular 15-minute follow-up visit at 3 months. For the 12
months follow up visit, the patient will visit the outpatient clinic for the
study only and will be compensated for travel expenses. The duration of the
operation is estimated at 1.5 hours. One hour for fat grafting of other scars
(standard care), and maximum half an hour extra for the intervention:
optionally taking a 2mm biopsy, liposuction, production of SVF, mixing the fat
graft with SVF and adhesiolysis and injection under the scar (of which 10
minutes is standard care).
A 2mm biopsy of the adherent scar is optional for patients and performed by a
plastic surgeon under full or local anaesthesia at two time-points, one during
the operation (i.e. pre-grafting, full anaesthesia) and one at the 12 months
follow up visit (local anaesthesia).
Vondellaan 13
Beverwijk 1942LE
NL
Vondellaan 13
Beverwijk 1942LE
NL
Listed location countries
Age
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
- 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
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 |
|---|---|
| Other | NL 8461 |
| CCMO | NL72094.000.20 |