Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin

NCT01313182 | Completed Phase 4 Results

• 1 other identifier: 11318
• Study Type: interventional
• Target: 1,874
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression. Our overall study objective is to measure the rate of deep and superficial Surgical Site Infections (SSIs) after primary hip, knee, shoulder and elbow arthroplasty surgery and primary spinal fusion surgery requiring implantation of prosthetic material, when the patient receives either nasal mupirocin or nasal povidone-iodine prior to surgery. Secondary study objectives include:

1. 1.Measure hospital length of stay and re-admission rates in the mupirocin and povidone-iodine groups.
2. 2.Measure adverse events related to mupirocin and povidone-iodine.
3. 3.Measure rate of SA resistance to mupirocin.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infections Occurring Within 12 Months of Surgical Procedure

  Measure the rate (number and percent of patients) with deep and superficial surgical site infections after primary orthopedic surgery and primary spinal fusion surgery requiring implantation of prosthetic material.

  12 months

Secondary Outcomes (3)

• Measure Hospital Length of Stay in the Mupirocin and Povidone-iodine Groups.

  Post-surgery

• Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.

  Isolates collected and frozen immediately post-surgery.

• Re-admission Rates in the Mupirocin and Povidone-iodine Groups.

  12 months

Study Arms (2)

3M Skin and Nasal Antiseptic

ACTIVE COMPARATOR

Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation

Drug: 3M Skin and Nasal Antiseptic

Bactroban Nasal

ACTIVE COMPARATOR

Mupirocin calcium ointment, 2%

Drug: mupirocin calcium ointment, 2%

Interventions

mupirocin calcium ointment, 2% DRUG

Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days. After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.

Also known as: Bactroban Nasal

Bactroban Nasal

3M Skin and Nasal Antiseptic DRUG

The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds.

Also known as: 3M Skin and Nasal Antiseptic Povidone-iodine solution

3M Skin and Nasal Antiseptic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary arthroplasty or spinal fusion surgery
• Age greater than 18 years

You may not qualify if:

• Revision arthroplasty
• Revision spinal fusion surgery
• Primary spine surgery without implantation of prosthetic material
• Allergy to mupirocin
• Allergy to povidone-iodine
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• Solventum US LLC: lead
• New York University: collaborator
• 3M: collaborator

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10003, United States

Location

Related Publications (1)

• Phillips M, Rosenberg A, Shopsin B, Cuff G, Skeete F, Foti A, Kraemer K, Inglima K, Press R, Bosco J. Preventing surgical site infections: a randomized, open-label trial of nasal mupirocin ointment and nasal povidone-iodine solution. Infect Control Hosp Epidemiol. 2014 Jul;35(7):826-32. doi: 10.1086/676872. Epub 2014 May 21.

  PMID: 24915210 RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study failed to achieve target enrollment. The small sample size precluded a multivariate analysis. Nasal culture alone was used as a screen for S. aureus colonization, which has a sensitivity of only 48% to 66%.

Results Point of Contact

• Title: Dr. Michael Phillips
• Organization: New York University School of Medicine

michael.phillips@nyumc.org

212 263 4316

Study Officials

• Michael Phillips, MD

  NYU Langone Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: March 11, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 2, 2024
• Results First Posted: May 19, 2014

Record last verified: 2024-11

Locations

US (1)