Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| New York University | OTHER |
| 3M | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M Skin and Nasal Antiseptic | Active Comparator | Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation |
|
| Bactroban Nasal | Active Comparator | Mupirocin calcium ointment, 2% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-surgery |
| Measure Rate of Staphylococcus Aureus Resistance to Mupirocin. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Phillips, MD | NYU Langone Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24915210 | Result | 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. |
Not provided
Not provided
Only patients receiving surgery were considered Started.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
arthroplasty or spine fusion surgery patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 12 months |
|
3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Vascular disorders | Non-systematic Assessment |
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%.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Phillips | New York University School of Medicine | 212 263 4316 | michael.phillips@nyumc.org |
Not provided
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
|
|
Lab cultured isolates - they will measure rate of Staphylococcus aureus resistance to mupirocin. Both arms were sampled and tested post-op.
| Isolates collected and frozen immediately post-surgery. |
| Re-admission Rates in the Mupirocin and Povidone-iodine Groups. | Re-admission rates in the Mupirocin and Povidone-iodine Groups. | 12 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
|
|
| 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. | Data was not collected for this assessment. | Posted | Post-surgery |
|
|
| 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. | Posted | Count of Participants | Participants | Isolates collected and frozen immediately post-surgery. |
|
|
|
| Secondary | Re-admission Rates in the Mupirocin and Povidone-iodine Groups. | Re-admission rates in the Mupirocin and Povidone-iodine Groups. | Data was not collected for this assessment. | Posted | 12 months |
|
|
| 0 |
| 842 |
| 0 |
| 842 |
| 15 |
| 842 |
| EG001 | 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. | 0 | 855 | 0 | 855 | 76 | 855 |
| Rhinorrhea | General disorders | Non-systematic Assessment |
|
| Nasal irritation | General disorders | Non-systematic Assessment |
|
| Congestion | General disorders | Non-systematic Assessment |
|
| Cough | General disorders | Non-systematic Assessment |
|
| Pharyngeal pain | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |