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

Solventum US LLC

Status and phase: Completed; Phase 4

Conditions: Surgical Site Infection

Treatments: Drug: 3M Skin and Nasal Antiseptic; Drug: mupirocin calcium ointment, 2%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01313182

11318

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,874 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,874 participants in 2 patient groups

3M Skin and Nasal Antiseptic

Active Comparator group

Description:

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

Treatment:

Drug: 3M Skin and Nasal Antiseptic

Bactroban Nasal

Active Comparator group

Description:

Mupirocin calcium ointment, 2%

Treatment:

Drug: mupirocin calcium ointment, 2%