NCT02652325

Brief 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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

First QC Date

January 6, 2016

Last Update Submit

January 8, 2016

Conditions

MRSA/ MSSA Colonization of the Nares

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    24 hours

Study Arms (3)

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

Interventions

SalineDRUG
Saline
Povidone-IodineDRUG
povidone-iodine
5% Povidone-Iodine USP swabsDRUG
3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP swabs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All potential total hip and total knee arthroplasty candidates
  • All femoroacetabular osteoplasty patients
  • All pelvic acetabular osteotomy patients
  • All core decompression patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28578841DERIVED

MeSH Terms

Interventions

Sodium ChloridePovidone-Iodine

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsIodophorsIodine CompoundsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 11, 2016

Primary Completion

February 1, 2016

Last Updated

January 11, 2016

Record last verified: 2016-01