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

MRSA/ MSSA Colonization of the Nares Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02652325
• Other study ID #: 2016JPAR
• Status: Active, not recruiting
• Phase: N/A
• First received: January 6, 2016
• Last updated: January 8, 2016

Study information

• Verified date: January 2016
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• MRSA/ MSSA Colonization of the Nares

Intervention

Drug:
• Saline

• Povidone-Iodine

• 5% Povidone-Iodine USP swabs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No