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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Fat Grafting | Study protocol

Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial

Authors: Linda Vriend, Joris A. van Dongen, Anouk Pijpe, Marianne K. Nieuwenhuis, Sandra J. M. Jongen, Martin C. Harmsen, Paul P. M. van Zuijlen, Berend van der Lei

Published in: Trials | Issue 1/2022

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Abstract

Background

In the last decades, autologous fat grafting has been used to treat adherent dermal scars. The observed regenerative and scar-reducing properties have been mainly ascribed to the tissue-derived stromal vascular fraction (tSVF) in adipose tissue. Adipose tissue’s components augment local angiogenesis and mitosis in resident tissue cells. Moreover, it promotes collagen remodeling. We hypothesize that tSVF potentiates fat grafting-based treatment of adherent scars. Therefore, this study aims to investigate the effect of tSVF-enriched fat grafting on scar pliability over a 12-month period.

Methods and design

A clinical multicenter non-randomized early phase trial will be conducted in two dedicated Dutch Burn Centers (Red Cross Hospital, Beverwijk, and Martini Hospital, Groningen). After informed consent, 46 patients (≥18 years) with adherent scars caused by burns, necrotic fasciitis, or degloving injury who have an indication for fat grafting will receive a sub-cicatricic tSVF-enriched fat graft. The primary outcome is the change in scar pliability measured by the Cutometer between pre- and 12 months post-grafting. Secondary outcomes are scar pliability (after 3 months), scar erythema, and melanin measured by the DSM II Colormeter; scar quality assessed by the patient and observer scales of the Patient and Observer Scar Assessment Scale (POSAS) 2.0; and histological analysis of scar biopsies (voluntary) and tSVF quality and composition. This study has been approved by the Dutch Central Committee for Clinical Research (CCMO), NL72094.000.20.

Conclusion

This study will test the clinical efficacy of tSVF-enriched fat grafting to treat dermal scars while the underlying working mechanism will be probed into too.

Trial registration

Dutch Trial Register NL 8461. Registered on 16 March 2020
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Metadata
Title
Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial
Authors
Linda Vriend
Joris A. van Dongen
Anouk Pijpe
Marianne K. Nieuwenhuis
Sandra J. M. Jongen
Martin C. Harmsen
Paul P. M. van Zuijlen
Berend van der Lei
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Fat Grafting
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06514-3

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