Evidence map›Paper›PMID 33051871›Full record

Trial reportJournal of surgical oncology2021

First-year complications after immediate breast reconstruction with a biological and a synthetic mesh in the same patient: A randomized controlled study.

Emma Hansson, Ann-Chatrin Edvinsson, Anna Elander, Lars Kölby, Håkan Hallberg

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of surgical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02985073 (The Gothenburg TIGR/Veritas® Study - A Comparison Between Biological), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 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.

NCT02985073 nacompletednot on this map

The Gothenburg TIGR/Veritas® Study - A Comparison Between Biological (Veritas®) vs Non Biological Mesh (TIGR®) in Immediate Breast Reconstruction

TypeinterventionalSponsorVastra Gotaland RegionRan2016 to 2022Enrolled24ConditionsBreast CancerArmsVeritas®, TIGR®
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

5 authors.

Emma HanssonDepartment of Plastic Surgery, Institute of Clinical Sciences, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.ORCID http://orcid.org/0000-0002-3218-0881
Ann-Chatrin EdvinssonDepartment of Plastic Surgery, Institute of Clinical Sciences, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.
Anna ElanderDepartment of Plastic Surgery, Institute of Clinical Sciences, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.
Lars KölbyDepartment of Plastic Surgery, Institute of Clinical Sciences, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.
Håkan HallbergDepartment of Plastic Surgery, Institute of Clinical Sciences, The Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.

Funding

Grants from the federal government under the ALF agreement ALFGBG-724171The Percy Falk Foundation for research into prostate cancer and breast cancer
6 · The paper itself

Abstract

backgroundEven though meshes and matrices are widely used in breast reconstruction, there is little high-quality scientific evidence for their risks and benefits. The aim of this study was to compare first-year surgical complication rates in implant-based immediate breast reconstruction with a biological mesh with that of a synthetic mesh, in the same patient.

methodsThis study is a clinical, randomized, prospective trial. Patients operated on with bilateral mastectomy and immediate breast reconstruction were randomized to biological mesh on one side and synthetic mesh on the other side.

resultsA total of 48 breasts were randomized. As the synthetically and the biologically reconstructed breasts that were compared belonged to the same woman, systemic factors were exactly the same in the two groups. The most common complication was seroma formation with a frequency of 38% in the biological group and 3.8% in the synthetical group (p = .011). A higher frequency of total implant loss could be seen in the biologic mesh group (8.5% vs. 2%), albeit not statistically significant (p = .083).

conclusionsIn the same patient, a synthetic mesh seems to yield a lower risk for serious complications, such as implant loss, than a biological mesh.

Indexed as

AdultAgedBreast ImplantationBreast ImplantsBreast NeoplasmsFemaleFollow-Up StudiesHumansMammaplastyMastectomyMiddle AgedPostoperative ComplicationsPrognosisProspective StudiesSurgical Meshacellular dermal matrixcomplicationsimmediate breast reconstructionsynthetic meshTIGRVeritas

Identifiers

PMID33051871
PMCPMC7821308

What OpenQuestion holds

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Registered trials

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.