TY - JOUR
T1 - Stromal vascular fraction-enriched fat grafting as treatment of adherent scars
T2 - study design of a non-randomized early phase trial
AU - Vriend, Linda
AU - van Dongen, Joris A.
AU - Pijpe, Anouk
AU - Nieuwenhuis, Marianne K.
AU - Jongen, Sandra J. M.
AU - Harmsen, Martin C.
AU - van Zuijlen, Paul P. M.
AU - van der Lei, Berend
N1 - Funding Information: This study is partially funded by the Netherlands Organisation for Health Research and Development (ZonMw), project number: 427002011, and the Dutch Burn Foundation. Funding Information: We would like to thank the Netherlands Organisation for Health Research and Development (ZonMw) and the Dutch Burn Foundation for their financial contribution. Publisher Copyright: © 2022, The Author(s).
PY - 2022/12/1
Y1 - 2022/12/1
N2 - 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.
AB - 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.
KW - ASC
KW - Adherent scars
KW - Adipose-derived stromal cells
KW - Burn scars
KW - Fat grafting
KW - Pliability
KW - Scar quality
KW - Stromal vascular fraction
UR - http://www.scopus.com/inward/record.url?scp=85134366492&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-022-06514-3
DO - https://doi.org/10.1186/s13063-022-06514-3
M3 - Article
C2 - 35854356
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 575
ER -