Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial
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 augmen...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2022-07-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06514-3 |
| _version_ | 1828784769002897408 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Linda Vriend |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-12-11T23:37:35Z |
| format | Article |
| id | doaj.art-2bf13292757e40b58b95d3ce10e8f688 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T23:37:35Z |
| publishDate | 2022-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-2bf13292757e40b58b95d3ce10e8f6882022-12-22T00:45:49ZengBMCTrials1745-62152022-07-0123111010.1186/s13063-022-06514-3Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trialLinda Vriend0Joris A. van Dongen1Anouk Pijpe2Marianne K. Nieuwenhuis3Sandra J. M. Jongen4Martin C. Harmsen5Paul P. M. van Zuijlen6Berend van der Lei7Department of Pathology & Medical Biology, University of Groningen, University Medical Center GroningenDepartment of Pathology & Medical Biology, University of Groningen, University Medical Center GroningenBurn Center, Red Cross HospitalAssociation of Dutch Burn Centers, Martini HospitalAssociation of Dutch Burn Centers, Martini HospitalDepartment of Pathology & Medical Biology, University of Groningen, University Medical Center GroningenBurn Center, Red Cross HospitalDepartment of Plastic Surgery, University of Groningen and University Medical Center of GroningenAbstract 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 2020https://doi.org/10.1186/s13063-022-06514-3Adherent scarsScar qualityBurn scarsStromal vascular fractionAdipose-derived stromal cellsASC |
| spellingShingle | 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 Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial Trials Adherent scars Scar quality Burn scars Stromal vascular fraction Adipose-derived stromal cells ASC |
| title | 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_short | 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 |
| topic | Adherent scars Scar quality Burn scars Stromal vascular fraction Adipose-derived stromal cells ASC |
| url | https://doi.org/10.1186/s13063-022-06514-3 |
| work_keys_str_mv | AT lindavriend stromalvascularfractionenrichedfatgraftingastreatmentofadherentscarsstudydesignofanonrandomizedearlyphasetrial AT jorisavandongen stromalvascularfractionenrichedfatgraftingastreatmentofadherentscarsstudydesignofanonrandomizedearlyphasetrial AT anoukpijpe stromalvascularfractionenrichedfatgraftingastreatmentofadherentscarsstudydesignofanonrandomizedearlyphasetrial AT marianneknieuwenhuis stromalvascularfractionenrichedfatgraftingastreatmentofadherentscarsstudydesignofanonrandomizedearlyphasetrial AT sandrajmjongen stromalvascularfractionenrichedfatgraftingastreatmentofadherentscarsstudydesignofanonrandomizedearlyphasetrial AT martincharmsen stromalvascularfractionenrichedfatgraftingastreatmentofadherentscarsstudydesignofanonrandomizedearlyphasetrial AT paulpmvanzuijlen stromalvascularfractionenrichedfatgraftingastreatmentofadherentscarsstudydesignofanonrandomizedearlyphasetrial AT berendvanderlei stromalvascularfractionenrichedfatgraftingastreatmentofadherentscarsstudydesignofanonrandomizedearlyphasetrial |