Evidence map›Paper›PMID 37730855›Full record

ArticleSurgical endoscopy2023

Evaluation of hernia surgical meshes sterilised with ethylene oxide for adoption under UK regulations.

Alessandra Grillo, Zargham Hyder, Vivek Mudera, Alvena Kureshi

Open access · hybridAbstract read
In one paragraph

Article in Surgical endoscopy, 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
0.3field-weighted citation impact, top 38% 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

2 citing papers in PubMed, 1 citations in OpenAlex.

  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

4 authors at 3 institutions in 2 countries.

Alessandra GrilloCentre for 3D Models of Health and Disease, Division of Surgery & Interventional Science, UCL, London, UK. alessandra.grillo@ucl.ac.uk.ORCID 0000-0001-6482-8796
Zargham HyderHydermed Limited, Woodford Green, UK.
Vivek MuderaCentre for 3D Models of Health and Disease, Division of Surgery & Interventional Science, UCL, London, UK.
Alvena KureshiCentre for 3D Models of Health and Disease, Division of Surgery & Interventional Science, UCL, London, UK.
University College London · GBAzienda Sanitaria Locale Alessandria · ITHomerton University Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLow-cost meshes (LCM) have been successfully used in low-income countries (LIC) over the past decades, demonstrating comparable surgical outcomes to commercial meshes at a fraction of the cost. However, LIC sterilisation standards (autoclave sterilisation at 121 °C) do not meet UK regulations for medical devices, which require either ethylene oxide (EO) sterilisation or steam sterilisation at 134 °C. Therefore, the aim of this study was to sterilise UK LCM and characterise their mechanical properties and in vitro biocompatibility to verify whether EO sterilisation causes changes in the mechanical properties and biocompatibility of LCM.

methodsEO sterilised LCM were used. Uniaxial tensile tests were performed to measure mechanical properties. Biocompatibility was measured through viability and morphology of Human Dermal Fibroblasts (HDFs) cultured in mesh-conditioned media, and by calculating the metabolic activity and proliferation of HDFs attached on the meshes, with alamarBlue assay.

resultsBreak stress of LCM1 was significantly higher than LCM2 (p < 0.0001), while Young's modulus of LCM1 was significantly lower than LCM2 (p < 0.05) and there was no significant difference in break strain. Viability and morphology showed no significant difference between LCM and control. Attachment and proliferation of HDFs on LCM showed a better proliferation on LCM2 than LCM1, with values similar to the control at the final time point.

conclusionsWe demonstrated that EO sterilisation affects LCM mechanical properties, but they still have values closer to the native tissues than the commercially available ones. We also showed that in vitro biocompatibility of LCM2 is not affected by EO sterilisation, as HDFs attached and proliferated on the mesh, while EO affected attachment on LCM1. A more detailed cost analysis of the potential savings for healthcare systems around the world needs to be performed to strengthen the cost-effectiveness of this frugal innovation.

Indexed as

Ethylene OxideSurgical MeshHerniaHumansMaterials TestingUnited KingdomEthylene OxideEthylene oxideFrugal innovationHernia repairMosquito meshSterilisation

Identifiers

PMID37730855
PMCPMC10709235
OpenAlexW4386882282

What OpenQuestion holds

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LicenceCC BY
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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.