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

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...

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Published in:Trials
Main Authors: Vriend, Linda, van Dongen, Joris A., Pijpe, Anouk, Nieuwenhuis, Marianne K., Jongen, Sandra J. M., Harmsen, Martin C., van Zuijlen, Paul P. M., van der Lei, Berend
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Language:English
Published: BioMed Central 2022
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Study Protocol
SCAR
Online Access:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9295521/
http://www.ncbi.nlm.nih.gov/pubmed/35854356
https://doi.org/10.1186/s13063-022-06514-3
id ftpubmed:oai:pubmedcentral.nih.gov:9295521
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spelling ftpubmed:oai:pubmedcentral.nih.gov:9295521 2023-05-15T18:15:16+02:00 Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial Vriend, Linda van Dongen, Joris A. Pijpe, Anouk Nieuwenhuis, Marianne K. Jongen, Sandra J. M. Harmsen, Martin C. van Zuijlen, Paul P. M. van der Lei, Berend 2022-07-19 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9295521/ http://www.ncbi.nlm.nih.gov/pubmed/35854356 https://doi.org/10.1186/s13063-022-06514-3 en eng BioMed Central http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9295521/ http://www.ncbi.nlm.nih.gov/pubmed/35854356 http://dx.doi.org/10.1186/s13063-022-06514-3 © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. CC0 PDM CC-BY Trials Study Protocol Text 2022 ftpubmed https://doi.org/10.1186/s13063-022-06514-3 2022-07-31T02:09:27Z 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 Text SCAR PubMed Central (PMC) Trials 23 1
institution Open Polar
collection PubMed Central (PMC)
op_collection_id ftpubmed
language English
topic Study Protocol
spellingShingle Study Protocol
Vriend, Linda
van Dongen, Joris A.
Pijpe, Anouk
Nieuwenhuis, Marianne K.
Jongen, Sandra J. M.
Harmsen, Martin C.
van Zuijlen, Paul P. M.
van der Lei, Berend
Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial
topic_facet Study Protocol
description 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
format Text
author Vriend, Linda
van Dongen, Joris A.
Pijpe, Anouk
Nieuwenhuis, Marianne K.
Jongen, Sandra J. M.
Harmsen, Martin C.
van Zuijlen, Paul P. M.
van der Lei, Berend
author_facet Vriend, Linda
van Dongen, Joris A.
Pijpe, Anouk
Nieuwenhuis, Marianne K.
Jongen, Sandra J. M.
Harmsen, Martin C.
van Zuijlen, Paul P. M.
van der Lei, Berend
author_sort Vriend, Linda
title Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial
title_short Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial
title_full Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial
title_fullStr Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial
title_full_unstemmed Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial
title_sort stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial
publisher BioMed Central
publishDate 2022
url http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9295521/
http://www.ncbi.nlm.nih.gov/pubmed/35854356
https://doi.org/10.1186/s13063-022-06514-3
genre SCAR
genre_facet SCAR
op_source Trials
op_relation http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9295521/
http://www.ncbi.nlm.nih.gov/pubmed/35854356
http://dx.doi.org/10.1186/s13063-022-06514-3
op_rights © The Author(s) 2022
https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
op_rightsnorm CC0
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CC-BY
op_doi https://doi.org/10.1186/s13063-022-06514-3
container_title Trials
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