Evidence map›Paper›PMID 30775431›Full record

ReviewACS biomaterials science & engineering2019

A Trans-Atlantic Perspective on Stagnation in Clinical Translation of Antimicrobial Strategies for the Control of Biomaterial-Implant-Associated Infection.

Henk J Busscher, Volker Alt, Henny C van der Mei, Paul H Fagette, Werner Zimmerli, T Fintan Moriarty, Javad Parvizi, Gerhard Schmidmaier, Michael J Raschke, Thorsten Gehrke and 5 more

Open access · hybridAbstract readReview
In one paragraph

Review in ACS biomaterials science & engineering, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
5.7field-weighted citation impact, top 3% 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

11 citing papers in PubMed, 33 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Review
  6. ACS applied materials & interfaces · 2021
    Article
  7. Article
  8. Self-defensive antimicrobial biomaterial surfaces.Colloids and surfaces. B, Biointerfaces · 2020
    Article
  9. Review
  10. Antimicrobial coatings for orthopaedic implants - Ready for use?Journal of bone and joint infection · 2020
    Article
  11. 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

15 authors at 11 institutions in 5 countries.

Henk J BusscherUniversity of Groningen and University Medical Center Groningen, Department of Biomedical Engineering, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.
Volker AltDepartment of Trauma Surgery, University Hospital Giessen-Marburg, Rudolf-Buchheim strasse 7, 35392 Giessen, Germany.
Henny C van der MeiUniversity of Groningen and University Medical Center Groningen, Department of Biomedical Engineering, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.
Paul H FagetteUniversity of Groningen and University Medical Center Groningen, Department of Biomedical Engineering, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.
Werner ZimmerliBasel University Medical Clinic, Kantonsspital Baselland, Rheinstrasse 26, CH-4410 Liestal, Switzerland.
T Fintan MoriartyAO Research Institute Davos, Clavadelerstrasse 8, 7270 Davos Platz, Switzerland.
Javad ParviziDepartment of Orthopedic Surgery, Rothman Institute at Jefferson, Thomas Jefferson University, Center City Philadelphia, 925 Chestnut Street, Fifth Floor, Philadelphia, Pennsylvania 19107, United States.
Gerhard SchmidmaierDepartment of Orthopedic and Trauma Surgery, University of Heidelberg, Schlierbacher Landstrasse 200a, 69118 Heidelberg, Germany.
Michael J RaschkeDepartment of Trauma, Hand, and Reconstructive Surgery, University of Muenster, Albert-Schweizer-Campus, D-48149 Muenster, Germany.
Thorsten GehrkeDepartment of Orthopedic Joint Surgery and Endoprosthetics, HELIOS ENDO-Clinic, Holstenstrasse 2, 22767 Hamburg, Germany.
Roger BaystonSchool of Medicine, Queens Medical Center, University of Nottingham, Nottingham NG7 2UH, U.K.
Larry M BaddourDivisions of Infectious Diseases and Cardiovascular Diseases, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905, United States.
Lynn C WintertonBetter Vision Group, LLC, 808 Sandy Trail, Keller, Texas 76248, United States.
Rabih O DarouicheDepartments of Medicine, Surgery and PM&R, Baylor College of Medicine 1333 Moursund Avenue, Houston, Texas 77030, United States.
David W GraingerDepartments of Bioengineering, Pharmaceutics, and Pharmaceutical Chemistry, University of Utah, 30 South 2000 East, Salt Lake City, Utah 84112-5820, United States.
University Medical Center Groningen · NLAO Foundation · CHBaylor College of Medicine · USHeidelberg University · DEHelios Endo-Klinik Hamburg · DEKantonsspital Baselland · CHMayo Clinic · USThomas Jefferson University · USUniversitätsklinikum Gießen und Marburg · DEUniversity of Nottingham · GBUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Current regulatory requirements impede clinical translation and market introduction of many new antimicrobial combination implants and devices, causing unnecessary patient suffering, doctor frustration, and costs to healthcare payers. Regulatory requirements of antimicrobial combination implants and devices should be thoroughly revisited and their approval allowed based on enrichment of benefit demonstrations from high-risk patient groups and populations or device components to facilitate their clinical translation. Biomaterial implant and devices equipped with antimicrobial strategies and approved based on enrichment claims should be mandatorily enrolled in global registry studies supervised by regulatory agencies for a minimum five-year period or until statistically validated evidence for noninferiority or superiority of claims is demonstrated. With these recommendations, this trans-Atlantic consortium of academicians and clinicians takes its responsibility to actively seek to relieve the factors that stagnate downward clinical translation and availability of antimicrobial combination implants and devices. Improved dialogue between the various key players involved in the current translational blockade, which include patients, academicians and doctors, policymakers, regulatory agencies, manufacturers, and healthcare payers, is urgently needed.

Identifiers

PMID30775431
PMCPMC6373985
OpenAlexW2903475246

What OpenQuestion holds

Textmetadata
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.