Evidence map›Paper›PMID 35788634›Full record

ArticleAesthetic surgery journal2023

Multicenter Pivotal Study Demonstrates Safety and Efficacy of a New Cellulite Procedure: 3-Month Results.

W Grant Stevens, Jeremy B Green, Craig Layt, Michael S Kaminer, Jennifer Harrington, Larry Fan, Holly Wall, Sabrina Fabi, Mark R Magnusson

Abstract readMulticenter Study
In one paragraph

Article in Aesthetic surgery journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
  2. 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

9 authors.

W Grant StevensUniversity of Southern California, Keck School of Medicine, Marina del Rey, CA, USA.ORCID 0000-0001-5866-1336
Jeremy B Green
Craig Layt
Michael S Kaminer
Jennifer Harrington
Larry Fan
Holly Wall
Sabrina Fabi
Mark R MagnussonGriffith University, School of Medicine, Southport, Queensland, Australia and is an international editor for Aesthetic Surgery Journal.ORCID 0000-0001-5777-8284

Funding

Revelle Aesthetics, Inc
6 · The paper itself

Abstract

backgroundCellulite is an aesthetic condition affecting the appearance of skin in certain body regions and is associated with body dissatisfaction, psychosocial stress, and decreased quality of life. Previous studies established the safety and feasibility of a novel, minimally invasive device to identify and release septa responsible for cellulite depressions: targeted verifiable subcision (TVS).

objectivesThe objective of this single-arm, open-label, multicenter study was to evaluate the safety and efficacy of TVS for reducing the appearance of moderate to severe cellulite in adult women.

methodsAdult women aged 21 to 55 years and a BMI < 30 kg/m2 with moderate or severe cellulite on the buttocks and/or thighs were eligible to enroll at 9 sites. Endpoint data included results from 4 of the postprocedural follow-up visits at 24 hours, 7 days, 30 days, and 90 days. The primary endpoints were a mean ≥1 point reduction in the Cellulite Severity Scale at 90 days and no related serious adverse events at 30 days.

resultsSeventy-four female participants with a mean BMI of 24.8 ± 2.7 and age of 41.4 ± 7.4 years received this single procedure. The mean improvement in Cellulite Severity Scale (N = 68) was 1.5 ± 0.9 (P < 0.0001). There were no device-related serious adverse events at 30 days.

conclusionsTVS for selectively identifying and verifiably releasing septa responsible for cellulite depressions is an effective and safe means to improve the appearance of moderate to severe cellulite in adult women. LEVEL OF EVIDENCE: 2:

Indexed as

CellulitePatient SatisfactionAdultButtocksFemaleHumansQuality of LifeThighTreatment Outcome

Identifiers

PMID35788634
PMCPMC9897188

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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.