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

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02652325
• Collaborator: (none)
• Arms: 3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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
• Anticipated Primary Completion Date: Feb 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. MSSA/MRSA colonization in the nares [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT02652325
• Other Study ID Numbers: 2016JPAR
• First Posted: Jan 11, 2016
• Last Update Posted: Jan 11, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Iodine; Cadexomer iodine; Povidone-Iodine; Povidone

Study Results

No Results Posted as of Jan 11, 2016