WithdrawnPhase 4ACTRN12618001245280

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

Sponsor

Orthopaedic Research Institute of Queensland

Enrollment

8 participants

Start Date

Jan 30, 2020

Study Type

Interventional

Conditions

Nasal Decolonisation Surgical Site Infection Infection

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Inclusion Criteria4

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

Exclusion Criteria5

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

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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 a

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.