Evidence map›Paper›PMID 35854356›Full record

ArticleTrials2022

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

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

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Linda VriendDepartment of Pathology & Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.ORCID http://orcid.org/0000-0002-9439-5810
Joris A van DongenDepartment of Pathology & Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Anouk PijpeBurn Center, Red Cross Hospital, Beverwijk, the Netherlands.
Marianne K NieuwenhuisAssociation of Dutch Burn Centers, Martini Hospital, Groningen, the Netherlands.
Sandra J M JongenAssociation of Dutch Burn Centers, Martini Hospital, Groningen, the Netherlands.
Martin C HarmsenDepartment of Pathology & Medical Biology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Paul P M van ZuijlenBurn Center, Red Cross Hospital, Beverwijk, the Netherlands.
Berend van der LeiDepartment of Plastic Surgery, University of Groningen and University Medical Center of Groningen, Groningen, the Netherlands. b.van.der.lei@umcg.nl.
University Medical Center Groningen · NLAssociation of Dutch Burn Centres · NLEmma Kinderziekenhuis · NL

Funding

ZonMw 427002011
6 · The paper itself

Abstract

backgroundIn 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

designA 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.

conclusionThis 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 registrationDutch Trial Register NL 8461. Registered on 16 March 2020.

Indexed as

CicatrixStromal Vascular FractionAdipose TissueClinical Trials as TopicHumansMulticenter Studies as TopicTransplantation, AutologousTreatment OutcomeAdherent scarsAdipose-derived stromal cellsASCBurn scarsFat graftingPliabilityScar qualityStromal vascular fraction

Identifiers

PMID35854356
PMCPMC9295521
OpenAlexW4285796283

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.