Evidence map›Paper›PMID 31351491›Full record

ArticleBMC pharmacology & toxicology2019

Povidone-iodine ear wash and oral cotrimoxazole for chronic suppurative otitis media in Australian aboriginal children: study protocol for factorial design randomised controlled trial.

Christine Wigger, Amanda Jane Leach, Jemima Beissbarth, Victor Oguoma, Ruth Lennox, Sandra Nelson, Hemi Patel, Mark Chatfield, Kathy Currie, Harvey Coates and 6 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pharmacology & toxicology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 9 pooled it
1.7field-weighted citation impact, top 17% 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

10 citing papers in PubMed, 9 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Antibiotics versus topical antiseptics for chronic suppurative otitis media.The Cochrane database of systematic reviews · 2025
    Pooled it
  2. Topical versus systemic antibiotics for chronic suppurative otitis media.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. Topical antiseptics for chronic suppurative otitis media.The Cochrane database of systematic reviews · 2025
    Pooled it
  4. Aural toilet (ear cleaning) for chronic suppurative otitis media.The Cochrane database of systematic reviews · 2025
    Pooled it
  5. Systemic antibiotics for chronic suppurative otitis media.The Cochrane database of systematic reviews · 2025
    Pooled it
  6. Topical versus systemic antibiotics for chronic suppurative otitis media.The Cochrane database of systematic reviews · 2021
    Pooled it
  7. Systemic antibiotics for chronic suppurative otitis media.The Cochrane database of systematic reviews · 2021
    Pooled it
  8. Aural toilet (ear cleaning) for chronic suppurative otitis media.The Cochrane database of systematic reviews · 2020
    Pooled it
  9. Topical antibiotics with steroids for chronic suppurative otitis media.The Cochrane database of systematic reviews · 2020
    Pooled it
  10. Complete genome sequence ofMicrobiology resource announcements · 2024
    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

16 authors at 7 institutions in 1 country.

Christine WiggerMenzies School of Health Research, PO Box 41096, Casuarina, Darwin, NT, 0812, Australia. Christine.wigger@menzies.edu.au.
Amanda Jane LeachMenzies School of Health Research, PO Box 41096, Casuarina, Darwin, NT, 0812, Australia.
Jemima BeissbarthMenzies School of Health Research, PO Box 41096, Casuarina, Darwin, NT, 0812, Australia.
Victor OguomaMenzies School of Health Research, PO Box 41096, Casuarina, Darwin, NT, 0812, Australia.
Ruth LennoxMenzies School of Health Research, PO Box 41096, Casuarina, Darwin, NT, 0812, Australia.
Sandra NelsonTop End Health Services, Darwin, Northern Territory, Australia.
Hemi PatelRoyal Darwin Hospital, Darwin, Northern Territory, Australia.
Mark ChatfieldUniversity of Queensland, Brisbane, Queensland, Australia.
Kathy CurrieNorthern Territory Department of Health, Darwin, Northern Territory, Australia.
Harvey CoatesUniversity of Western Australia, Perth, Western Australia, Australia.
Keith EdwardsTop End Health Services, Darwin, Northern Territory, Australia.
Heidi Smith-VaughanMenzies School of Health Research, PO Box 41096, Casuarina, Darwin, NT, 0812, Australia.
Kim HareMenzies School of Health Research, PO Box 41096, Casuarina, Darwin, NT, 0812, Australia.
Paul TorzilloRoyal Prince Alfred Hospital, Camperdown, New South Wales, Australia.
Steven TongRoyal Melbourne Hospital, Melbourne, Victoria, Australia.
Peter MorrisRoyal Darwin Hospital, and Menzies School of Health Research, Darwin, Northern Territory, Australia.
Menzies School of Health Research · AUNorthern Territory Health Services · AURoyal Darwin Hospital · AURoyal Prince Alfred Hospital · AUThe Royal Melbourne Hospital · AUUniversity of Queensland · AUUniversity of Western Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic suppurative otitis media (CSOM) is a significant health issue affecting Aboriginal Australians. Long-term hearing loss can cause communication problems, educational disadvantage, and social isolation. Current standard treatment for CSOM in our region is twice daily dry mopping of the pus from the ear canal followed by instillation of ciprofloxacin antibiotic ear drops for up to 16 weeks, or until the discharge resolves for a period of 3 days. The treatment is long, laborious and fails to resolve ear discharge in 70% of cases in remote communities. Bacterial pathogens also persist. Povidone-iodine ear wash is the preferred method of clearing ear discharge in Western Australia. However, evidence of its effectiveness is lacking. In systematic reviews, topical antibiotics (ciprofloxacin) have been shown to be more effective than oral antibiotics or topical antiseptics. Currently, it is unclear whether there are any benefits of combining these treatments.

methodsThis protocol describes a 2 × 2 factorial randomised controlled trial of two different interventions (povidone-iodine ear wash and oral cotrimoxazole), given as adjunctive therapy to standard treatment for CSOM. 280 children, between 2 months and 17 years of age, Indigenous or non-Indigenous, living in participating Northern Territory (NT) communities are randomised to standard treatment (dry mopping and ciprofloxacin drops) plus one of two topical treatments (dilute povidone-iodine ear wash or no wash) and one of two oral medication treatments (16 weeks of cotrimoxazole or placebo). DISCUSSION: Current treatment of CSOM in our region shows that eradication of bacterial pathogens from the middle ear space and dry ears is often not achieved. This trial will evaluate the efficacy of adjunctive treatments of antiseptic ear washes and oral antibiotics. Clinical, microbiological and hearing outcomes will be reported.

trial registrationThis trial (ACTRN12614000234617) was registered with ANZCTR on 05 April 2014.

Indexed as

Randomized Controlled Trials as TopicAdministration, OralAdministration, TopicalAdolescentAnti-Bacterial AgentsAnti-Infective Agents, LocalChildChild, PreschoolDrug Therapy, CombinationFemaleHumansInfantMaleOtitis Media, SuppurativePovidone-IodineSingle-Blind MethodAnti-Bacterial AgentsAnti-Infective Agents, LocalPovidone-IodineTrimethoprim, Sulfamethoxazole Drug CombinationAboriginalChildrenChronic suppurative otitis mediaCiprofloxacinCotrimoxazoleIndigenousPovidone-iodineRandomised controlled trial

Identifiers

PMID31351491
PMCPMC6660704
OpenAlexW2965064803

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.