Surgical Site InfectionPhase 4NCT01313182
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
A Phase 4 study testing mupirocin calcium ointment, 2% and 3M Skin and Nasal Antiseptic in people with Surgical Site Infection, run by Solventum US LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- mupirocin calcium ointment, 2% and 3M Skin and Nasal Antiseptic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,874 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Sep 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary arthroplasty or spinal fusion surgery
- Age greater than 18 years
Who cannot join
- Revision arthroplasty
- Revision spinal fusion surgery
- Primary spine surgery without implantation of prosthetic material
- Allergy to mupirocin
- Allergy to povidone-iodine
- Pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10003
About this study
Official title: Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine
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:
- Measure hospital length of stay and re-admission rates in the mupirocin and povidone-iodine groups.
- Measure adverse events related to mupirocin and povidone-iodine.
- Measure rate of SA resistance to mupirocin.
Read the 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.
- Conditions
- Surgical Site Infection
- Being tested
- mupirocin calcium ointment, 2%, 3M Skin and Nasal Antiseptic
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mupirocin calcium ointment, 2%Drug
Also called Bactroban Nasal
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.
3M Skin and Nasal AntisepticDrug
Also called 3M Skin and Nasal Antiseptic Povidone-iodine solution
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.
| Study group | Role | What they receive |
|---|---|---|
| 3M Skin and Nasal Antiseptic | Active comparator | Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation Receives: Drug: 3M Skin and Nasal Antiseptic |
| Bactroban Nasal | Active comparator | Mupirocin calcium ointment, 2% Receives: Drug: mupirocin calcium ointment, 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: Post-surgery
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,874 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New York University, 3M
- Responsible party
- Sponsor
- Investigators
- Michael Phillips, MD, Principal investigator, NYU Langone Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313182
- Sponsor's protocol ID
- 11318
- Status last verified
- Nov 2024
- First submitted
- 11 Feb 2011
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24915210
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine
- ClinicalTrials.gov ID
- NCT01313182
- Acronym / sponsor ID
- 11318
- Conditions
- Surgical Site Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,874 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- New York University, 3M
- Study start
- Mar 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Posted 19 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Measure hospital length of stay and re-admission rates in the mupirocin and povidone-iodine groups.
- Measure adverse events related to mupirocin and povidone-iodine.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3M Skin and Nasal Antiseptic | Active comparator | Drug: 3M Skin and Nasal AntisepticPovidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation |
| Bactroban Nasal | Active comparator | Drug: mupirocin calcium ointment, 2%Mupirocin calcium ointment, 2% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary arthroplasty or spinal fusion surgery
- Age greater than 18 years
Key exclusion criteria (7 listed)
- Revision arthroplasty
- Revision spinal fusion surgery
- Primary spine surgery without implantation of prosthetic material
- Allergy to mupirocin
- Allergy to povidone-iodine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mupirocin calcium ointment, 2%Also: Bactroban NasalApproximately 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. | Drug | Bactroban Nasal |
| 3M Skin and Nasal AntisepticAlso: 3M Skin and Nasal Antiseptic Povidone-iodine solutionThe 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. | Drug | 3M Skin and Nasal Antiseptic |
Primary outcome
Surgical Site Infections Occurring Within 12 Months of Surgical Procedure
Time frame: 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.
3 secondary outcomes
Measure Hospital Length of Stay in the Mupirocin and Povidone-iodine Groups.
Time frame: Post-surgery
Measure Rate of Staphylococcus Aureus Resistance to Mupirocin.
Time frame: Isolates collected and frozen immediately post-surgery.
Re-admission Rates in the Mupirocin and Povidone-iodine Groups.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24915210Phillips 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Phillips, MD principal investigator
NYU Langone Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mupirocin calcium ointment, 2% and 3M Skin and Nasal Antiseptic in people with Surgical Site Infection, run by Solventum US LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infections Occurring Within 12 Months of Surgical Procedure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01313182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.