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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

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ClinicalTrials.gov Identifier: NCT02652325
Recruitment Status : Unknown
Verified January 2016 by Rothman Institute Orthopaedics.
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2016
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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.

Condition or disease Intervention/treatment Phase
MRSA/ MSSA Colonization of the Nares Drug: Saline Drug: Povidone-Iodine Drug: 5% Povidone-Iodine USP swabs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Estimated Primary Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Placebo Comparator: Saline Drug: Saline



Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT02652325    
Other Study ID Numbers: 2016JPAR
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes