Evidence map›Paper›PMID 30881804›Full record

ArticlePlastic and reconstructive surgery. Global open2018

Cortiva Versus AlloDerm Ready-to-use in Prepectoral and Submuscular Breast Reconstruction: Prospective Randomized Clinical Trial Study Design and Early Findings.

Rajiv P Parikh, Marissa M Tenenbaum, Yan Yan, Terence M Myckatyn

Abstract read
In one paragraph

Article in Plastic and reconstructive surgery. Global open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–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

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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  8. Review
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  11. Surgical Outcomes in Prepectoral Breast Reconstruction.Plastic and reconstructive surgery. Global open · 2020
    Article
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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

4 authors.

Rajiv P ParikhDivision of Plastic and Reconstructive Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, Mo.
Marissa M TenenbaumDivision of Plastic and Reconstructive Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, Mo.
Yan YanDivision of Public Health Sciences, Department of Surgery, Washington University School of Medicine, St. Louis, Mo.
Terence M MyckatynDivision of Plastic and Reconstructive Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, Mo.

Funding

Postdoctoral Training in Cancer Prevention and ControlT32CA190194 · NCI · WASHINGTON UNIVERSITY · PI GRAHAM A. COLDITZ, AIMEE S JAMES · 2014 to 2026
$4.7M
NCI NIH HHS T32 CA190194
6 · The paper itself

Abstract

backgroundSeveral acellular dermal matrices (ADMs) can be used to provide soft-tissue support for post- and prepectoral prosthetic breast reconstructions. Yet, several recent meta-analysis suggest that due to a lack of rigorous evaluation in the setting of head-to-head prospective randomized control trials, few reliable conclusions regarding performance outcomes can be drawn. We compare Cortiva 1 mm to AlloDerm RTU in the setting of submuscular reconstruction in one study, and prepectoral in the second. Moreover, we present the findings from the interim analysis in our submuscular study.

methodsUsing a single-blinded prospective randomized control trial design, we compare outcomes in 180 patients undergoing submuscular breast reconstruction with 16 × 8 cm ADM support (either Cortiva 1 mm or AlloDerm RTU). A parallel study evaluates 16 × 20 cm sheets of these ADMs in 180 patients undergoing prepectoral reconstructions. Time to drain removal, complications, fill volumes, patient-reported outcomes, and narcotic consumption are prospectively evaluated.

resultsInterim analysis of 59 breasts in the submuscular study arm (Cortiva n = 31; AlloDerm n = 28) revealed no statistically significant differences with respect to outcome. At the time of interim analysis, the AlloDerm RTU group contained a higher proportion of never-smokers (

conclusionWe present a protocol for a robust randomized control trial to evaluate outcomes in both submuscular and prepectoral prosthetic breast reconstruction assisted by 2 distinct types of ADM. Our interim analysis reveals no evidence of inferiority of outcomes in a comparison of AlloDerm to Cortiva.

Identifiers

PMID30881804
PMCPMC6414118

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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.