Evidence map›Paper›PMID 30068306›Full record

Trial reportBMC infectious diseases2018

A randomized, controlled study to investigate the efficacy and safety of a topical gentamicin-collagen sponge in combination with systemic antibiotic therapy in diabetic patients with a moderate or severe foot ulcer infection.

Ilker Uçkay, Benjamin Kressmann, Sarah Malacarne, Anna Toumanova, Jaafar Jaafar, Daniel Lew, Benjamin A Lipsky

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01951768 (A Randomized, Controlled Study to Investigate the Efficacy and Safety of a Topical Gentamicin-Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 7% 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.

NCT01951768 phase4completednot on this map

A Randomized, Controlled Study to Investigate the Efficacy and Safety of a Topical Gentamicin-Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection

TypeinterventionalSponsorUniversity Hospital, GenevaRan2013 to 2016Enrolled88ConditionsDiabetic Foot UlcerArmsGaramycin Sponge (Gentamicin-Collagen sponge), Systemic Antibiotic
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Wound Dressing Modifications for Accelerated Healing of Infected Wounds.International journal of molecular sciences · 2023
    Review
  13. Article
  14. Article
  15. Review
  16. Exploring the Role ofToxins · 2022
    Review
  17. Pseudomonal Diabetic Foot Infections: Vive la Différence?Mayo Clinic proceedings. Innovations, quality & outcomes · 2022
    Article
  18. Article
  19. Review
  20. Review
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

7 authors at 2 institutions in 2 countries.

Ilker UçkayService of Infectious Diseases, Geneva, Switzerland. ilker.uckay@hcuge.ch.
Benjamin KressmannService of Infectious Diseases, Geneva, Switzerland.
Sarah MalacarneService of Diabetology and Endocrinology, Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland.
Anna ToumanovaOrthopaedic Surgery Service, Geneva, Switzerland.
Jaafar JaafarDivision of Medical Sciences, Green Templeton College, University of Oxford, Oxford, UK.
Daniel LewService of Infectious Diseases, Geneva, Switzerland.
Benjamin A LipskyService of Infectious Diseases, Geneva, Switzerland.
University of Oxford · GBUniversity of Geneva · CH

Funding

Innocoll Unconditional donation
6 · The paper itself

Abstract

backgroundAn adjunctive topical therapy with gentamicin-sponges to systemic antibiotic therapy might improve the healing of infected diabetic foot ulcers (DFUI).

methodsSingle-center, investigator-blinded pilot study, randomizing (1:1) the gentamicin-sponge with systemic antibiotic versus systemic antibiotics alone for patients with DFUI.

resultsWe included 88 DFUI episodes with 43 patients in the gentamicin-sponge arm and 45 in the control arm. Overall, 64 (64/88; 73%) witnessed total clinical cure, 13 (15%) significant improvement, and 46 (52%) showed total eradication of all pathogens at the final visit. Regarding final clinical cure, there was no difference in favour of the gentamicin-sponges (26/45 vs. 31/43; p = 0.16). However, the gentamicin-sponge arm tended to a more rapid healing. In multivariate analysis adjusting for the case-mix, the variable "gentamicin-sponge" was not significantly associated with "cure and improvement". Gentamicin-sponges were very well tolerated, without any attributed adverse events.

conclusionsThe gentamicin-sponge was very well tolerated, but did not significantly influence overall cure.

trial registrationClinicalTrials.gov ( NCT01951768 ). Date 2 April 2013.

Indexed as

Anti-Bacterial AgentsBandagesCollagenDiabetic FootGentamicinsHumansPilot ProjectsAnti-Bacterial AgentsCollagenGentamicinsCureDiabetic foot infectionsGentamicin spongePathogensSafety

Identifiers

PMID30068306
PMCPMC6090847
OpenAlexW2887833771

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.