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Betadine Sore Throat Gargle for removal of nasal Staphylococcus aureus

Application of Betadine Sore Throat Gargle for nasal decolonisation of Staphylococcus aureus: a within subject randomised crossover trial

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001245280
Enrollment
8
Registered
2018-07-24
Start date
2020-01-30
Completion date
2020-12-01
Last updated
2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to compare the effects of Betadine Sore Throat Gargle in decolonising nasal S. aureus, as well as to quantify the decrease in S. aureus numbers and the length of time it has an effect. This will be investigated in a healthy individual population who have persistent nasal colonisation with S. aureus. Three treatments will be compared. A control treatment with nasal application of saline. Mupirocin Nasal Ointment which is currently used for pre operative nasal decolonisation, and nasal application of Betadine Sore Throat Gargle. This is a crossover study design which means that each of the participants will receive all the three treatments. The outcomes examined in this study include to determine the efficacy of nasal application of Betadine Sore Throat Gargle in decolonising nasal S. aureus. To quantify the decrease in colony numbers. To determine the length of time Betadine sore throat gargle has an effect, and to see if it can provide absolute removal of nasal S. aureus. The findings of this study may help establish an alternative method of pre-operative nasal decolonisation of S. aureus.

Interventions

This study will have three treatment groups. Group 1 - Control (for nasal application) - 0.9% NaCl (sterile saline) - apply 1 soaked swab into each nostril for 30 seconds each, in two consecutive applications. At the end a total application time of 1 minute per nostril should be achieved. Repeat this twice a day (morning and evening), for total of 5 days. Group 2 - Mupirocin ointment cream (Bactroban ointment for nasal application) - Mupirocin 2% w/w active ingredient - approximately 0.5g into

This study will have three treatment groups. Group 1 - Control (for nasal application) - 0.9% NaCl (sterile saline) - apply 1 soaked swab into each nostril for 30 seconds each, in two consecutive applications. At the end a total application time of 1 minute per nostril should be achieved. Repeat this twice a day (morning and evening), for total of 5 days. Group 2 - Mupirocin ointment cream (Bactroban ointment for nasal application) - Mupirocin 2% w/w active ingredient - approximately 0.5g into each nostril twice a day (morning and evening) for total of 5 days. Group 3 - Betadine Sore Throat Gargle (nasal application) - Povidone Iodine 7.5% w/v active ingredient - apply 1 soaked swab into each nostril for 30 seconds each, in two consecutive applications. At the end a total application time of 1 minute per nostril should be achieved. Betadine Sore Throat gargle is a single application (once only). This is a crossover trial. A washout period of 2 weeks will be provided to each participant before commencing the next treatment. Participants will be self administering the treatments. Participants will be provided with information of how the treatments should be applied. Compliance to treatment will be monitored by the return of used treatment vials and as part of the evaluation question at the end of treatment.

Sponsors

Orthopaedic Research Institute of Queensland
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Individuals with persistent S. aureus colonisation (3 consecutive positive nasal swabs) Male and Female Age 18-90 Able to provide informed consent

Exclusion criteria

Individuals without S. aureus nasal colonisation or with intermittent colonisation (<3 consecutive positive swabs) Individuals unable to comply with assessment and application requirements Known hypersensitivity to iodine, povidone or mupirocin Pregnancy Individuals unable to provide informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026