Surgical Site Infection
Conditions
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. 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.
Detailed 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.
Interventions
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.
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.
Sponsors
New York University
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infections Occurring Within 12 Months of Surgical Procedure | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure Hospital Length of Stay in the Mupirocin and Povidone-iodine Groups. | Post-surgery | The hospital length of stay will be measured in the Mupirocin and Povidone-iodine groups. |
| Measure Rate of Staphylococcus Aureus Resistance to Mupirocin. | Isolates collected and frozen immediately post-surgery. | Lab cultured isolates - they will measure rate of Staphylococcus aureus resistance to mupirocin. Both arms were sampled and tested post-op. |
| Re-admission Rates in the Mupirocin and Povidone-iodine Groups. | 12 months | Re-admission rates in the Mupirocin and Povidone-iodine Groups. |
Countries
United States
Participant flow
Pre-assignment details
Only patients receiving surgery were considered Started.
Participants by arm
| Arm | Count |
|---|---|
| 3M Skin and Nasal Antiseptic Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation
Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: 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. | 842 |
| Bactroban Nasal Mupirocin calcium ointment, 2%
mupirocin calcium ointment, 2%: 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. | 855 |
| Total | 1,697 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 66 | 92 |
Baseline characteristics
| Characteristic | 3M Skin and Nasal Antiseptic | Bactroban Nasal | Total |
|---|---|---|---|
| Age, Continuous | 61.8 years | 62.4 years | 62.1 years |
| Region of Enrollment United States | 842 participants | 855 participants | 1697 participants |
| Sex: Female, Male Female | 499 Participants | 523 Participants | 1022 Participants |
| Sex: Female, Male Male | 343 Participants | 332 Participants | 675 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 842 | 0 / 855 |
| other Total, other adverse events | 15 / 842 | 76 / 855 |
| serious Total, serious adverse events | 0 / 842 | 0 / 855 |
Outcome results
Primary
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3M Skin and Nasal Antiseptic | Surgical Site Infections Occurring Within 12 Months of Surgical Procedure | 0 participants |
| Bactroban Nasal | Surgical Site Infections Occurring Within 12 Months of Surgical Procedure | 5 participants |
Secondary
Measure Hospital Length of Stay in the Mupirocin and Povidone-iodine Groups.
The hospital length of stay will be measured in the Mupirocin and Povidone-iodine groups.
Time frame: Post-surgery
Population: Data was not collected for this assessment.
Secondary
Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.
Lab cultured isolates - they will measure rate of Staphylococcus aureus resistance to mupirocin. Both arms were sampled and tested post-op.
Time frame: Isolates collected and frozen immediately post-surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3M Skin and Nasal Antiseptic | Measure Rate of Staphylococcus Aureus Resistance to Mupirocin. | 21 Participants |
| Bactroban Nasal | Measure Rate of Staphylococcus Aureus Resistance to Mupirocin. | 24 Participants |
Secondary
Re-admission Rates in the Mupirocin and Povidone-iodine Groups.
Re-admission rates in the Mupirocin and Povidone-iodine Groups.
Time frame: 12 months
Population: Data was not collected for this assessment.