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

January 8, 2016 updated by: Rothman Institute Orthopaedics

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All potential total hip and total knee arthroplasty candidates
  2. All femoroacetabular osteoplasty patients
  3. All pelvic acetabular osteotomy patients
  4. All core decompression patients

Exclusion Criteria:

  1. Any trauma patients
  2. Any tumor patients
  3. Any patient with periprosthetic joint infection
  4. Any patient with surgical site infection
  5. Any patient with known MRSA infection
  6. Any patients allergic to povidone-iodine
  7. Patients with thyroid disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline
Drug: Saline
Active Comparator: povidone-iodine
Drug: Povidone-Iodine
Active Comparator: 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP swabs
Drug: 5% Povidone-Iodine USP swabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 hours
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimate)

January 11, 2016

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016JPAR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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