MRSA/ MSSA Colonization of the NaresNCT02652325
Nasal Swab studyComparison of Effectiveness of Povidone-iodine Versus Saline Versus 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP Swabs for Decolonizing Intranasal MSSA/MRSA
A study testing Saline, Povidone-Iodine and 5% Povidone-Iodine USP swabs in people with MRSA/ MSSA Colonization of the Nares, run by Rothman Institute Orthopaedics.
Trial summary
To determine if routinely available 10% povidone-iodine swabs are more effective than saline and 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP for decolonizing MRSA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA/ MSSA Colonization of the Nares
- What is being tested?
- Saline, Povidone-Iodine and 5% Povidone-Iodine USP swabs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All potential total hip and total knee arthroplasty candidates
- All femoroacetabular osteoplasty patients
- All pelvic acetabular osteotomy patients
- All core decompression patients
Who cannot join
- Any trauma patients
- Any tumor patients
- Any patient with periprosthetic joint infection
- Any patient with surgical site infection
- Any patient with known MRSA infection
- Any patients allergic to povidone-iodine
- Patients with thyroid disease
About this study
Official title: Comparison of Effectiveness of Povidone-iodine Versus Saline Versus 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP Swabs for Decolonizing Intranasal MSSA/MRSA
To determine if routinely available 10% povidone-iodine swabs are more effective than saline and 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP for decolonizing MRSA.
- Conditions
- MRSA/ MSSA Colonization of the Nares
- Being tested
- Saline, Povidone-Iodine, 5% Povidone-Iodine USP swabs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Povidone-IodineDrug
5% Povidone-Iodine USP swabsDrug
| Study group | Role | What they receive |
|---|---|---|
| povidone-iodine | Active comparator | Not described Receives: Drug: Povidone-Iodine |
| 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP swabs | Active comparator | Not described Receives: Drug: 5% Povidone-Iodine USP swabs |
| Saline | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSSA/MRSA colonization in the nares
Subjects will undergo a swab of their nares to undergo PCR analysis to determine if they are effectively decolonized four hours after initial treatment
Measured: 4 hours
MSSA/MRSA colonization as tested by PCR
Subjects will undergo a swab of their nares to undergo PCR analysis to determine if they are effectively decolonized four hours after initial treatment
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Primary completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MRSA/ MSSA Colonization of the NaresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652325
- Sponsor's protocol ID
- 2016JPAR
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2016
- Last updated
- 11 Jan 2016
- Results posted
- No
Publications
Rezapoor M, Nicholson T, Tabatabaee RM, Chen AF, Maltenfort MG, Parvizi J. Povidone-Iodine-Based Solutions for Decolonization of Nasal Staphylococcus aureus: A Randomized, Prospective, Placebo-Controlled Study. J Arthroplasty. 2017 Sep;32(9):2815-2819. doi: 10.1016/j.arth.2017.04.039. Epub 2017 May 3.
PubMed 28578841
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Povidone-iodine Versus Saline Versus 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP Swabs for Decolonizing Intranasal MSSA/MRSA
- ClinicalTrials.gov ID
- NCT02652325
- Acronym / sponsor ID
- 2016JPAR
- Conditions
- MRSA/ MSSA Colonization of the Nares
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Primary completion
- Feb 2016 (estimated)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if routinely available 10% povidone-iodine swabs are more effective than saline and 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP for decolonizing MRSA.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| povidone-iodine | Active comparator | Drug: Povidone-Iodine |
| 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP swabs | Active comparator | Drug: 5% Povidone-Iodine USP swabs |
| Saline | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All potential total hip and total knee arthroplasty candidates
- All femoroacetabular osteoplasty patients
- All pelvic acetabular osteotomy patients
- All core decompression patients
Key exclusion criteria (7 listed)
- Any trauma patients
- Any tumor patients
- Any patient with periprosthetic joint infection
- Any patient with surgical site infection
- Any patient with known MRSA infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline | Drug | Saline |
| Povidone-Iodine | Drug | povidone-iodine |
| 5% Povidone-Iodine USP swabs | Drug | 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP swabs |
Primary outcome
MSSA/MRSA colonization in the nares
Time frame: 4 hours
Subjects will undergo a swab of their nares to undergo PCR analysis to determine if they are effectively decolonized four hours after initial treatment
MSSA/MRSA colonization as tested by PCR
Time frame: 24 hours
Subjects will undergo a swab of their nares to undergo PCR analysis to determine if they are effectively decolonized four hours after initial treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Derived from this study: PubMed 28578841Rezapoor M, Nicholson T, Tabatabaee RM, Chen AF, Maltenfort MG, Parvizi J. Povidone-Iodine-Based Solutions for Decolonization of Nasal Staphylococcus aureus: A Randomized, Prospective, Placebo-Controlled Study. J Arthroplasty. 2017 Sep;32(9):2815-2819. doi: 10.1016/j.arth.2017.04.039. Epub 2017 May 3.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Saline, Povidone-Iodine and 5% Povidone-Iodine USP swabs in people with MRSA/ MSSA Colonization of the Nares, run by Rothman Institute Orthopaedics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSSA/MRSA colonization in the nares (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02652325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.