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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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 |
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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 |
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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 |
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SCAR |
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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 PDM CC-BY |
op_doi |
https://doi.org/10.1186/s13063-022-06514-3 |
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