Screening and Decolonization for Staph Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find the best way to prevent surgical site infections caused by Staphylococcus aureus (SA), a common bacterium, in patients undergoing surgery. Researchers are comparing four methods to reduce SA bacteria in patients before surgery to determine the most effective one. Participants will either be screened for SA and treated with a specific bundle of treatments or receive one of three other combinations of nasal and body washes. This trial suits individuals scheduled for surgery in certain clinics, who have no current or recent antibiotic use, and can follow a pre-surgery treatment routine. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial requires that you do not take any antibiotics at the time of, or seven days before, the baseline cultures, and you cannot take any antibiotics before your surgery, except for standard pre-op antibiotics. Other medications are not mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study using a three-part treatment, including a nasal ointment called mupirocin, a mouth rinse with chlorhexidine gluconate (CHG), and a CHG body wash, showed promising results. This combination reduced infections after surgery and was generally well-tolerated by patients. Mupirocin, in particular, is well-researched and known to lower the risk of infections at the surgery site.
Research on nasal povidone iodine also shows it can help eliminate harmful bacteria before surgery. Although not as extensively studied, it has shown potential in reducing infections in some cases.
Studies found that nasal alcohol gel effectively lowered surgical site infections. In some cases, it was even considered better than mupirocin and was linked to a significant drop in infection rates.
Each treatment option has its own strengths and has been generally safe for participants in these studies.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative strategies to prevent Staphylococcus aureus (S. Aureus) infections in surgery outpatients, which can be a common and serious complication. Unlike standard treatments that might involve only topical antiseptics or antibiotics, this trial investigates multiple approaches, including screening for S. Aureus carriers and using a three-drug decolonization bundle. This bundle includes nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash, which is a comprehensive approach aiming to reduce infection rates more effectively. Additionally, the trial compares different preventive measures, such as nasal povidone iodine and nasal alcohol gel, allowing researchers to identify the most effective method for reducing surgical site infections. This comprehensive evaluation could lead to more tailored and effective prevention protocols, enhancing patient safety and outcomes.
What evidence suggests that this trial's treatments could be effective in eradicating Staphylococcus aureus carriage?
This trial will evaluate different methods for reducing Staphylococcus aureus (SA) in surgical patients. One arm will use a combination of nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash. Research has shown that these treatments can effectively reduce SA presence, potentially saving money and lowering infection risks after surgery.
Another arm will test nasal povidone iodine, which shows promise in reducing SA, especially when used correctly before surgery. It has proven effective in preventing infections in various surgical situations.
Additionally, the trial will include an arm using nasal alcohol gel. Some studies suggest that this gel may surpass mupirocin in reducing infections after surgery. It is easy to use, clean, and generally well-tolerated by patients. Each method will be assessed for its potential to reduce SA and improve surgical outcomes.12346Who Is on the Research Team?
Susan Kline, MD, MPH
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Decolonization
Participants undergo a decolonization process using different approaches, including nasal mupirocin, chlorhexidine gluconate body wash, and mouth rinse, or other specified treatments
Surgery and Immediate Postoperative Care
Participants undergo surgery and receive immediate postoperative care, including monitoring for surgical site infections
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on eradication of SA colonization and surgical site infections
What Are the Treatments Tested in This Trial?
Interventions
- Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening
- Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening
- No screening
- Screening and decolonization for SA carriers with the 3 drug bundle
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
giving nasal alcohol gel without screening
giving pre-op nasal povidone iodine without screening
giving pre-surgical patients the three drug decolonization bundle without screening. Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
non SA carriers in this arm will get two pre-op showers with an antiseptic soap
screening for SA carriage and using the three-drug decolonization bundle among patients with SA colonization
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Citations
Pre-surgical Nasal Decolonization of Staphylococcus aureus
This health technology assessment evaluates the effectiveness, safety, and cost-effectiveness of pre-surgical nasal decolonization of Staphylococcus aureus (S.
The efficacy of an alcohol-based nasal antiseptic versus ...
Meta-analyses found alcohol-based nasal antiseptic reduced surgical site infection. Alcohol-based nasal antiseptic was a superior alternative to mupirocin to ...
The efficacy of an alcohol-based nasal antiseptic versus ...
Meta-analyses found alcohol-based nasal antiseptic reduced surgical site infection. Alcohol-based nasal antiseptic was a superior alternative to mupirocin to ...
Study Details | NCT06378359 | Effectiveness of Screening ...
The primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all ...
5.
leapfroggroup.org
leapfroggroup.org/sites/default/files/Files/Nozin%20Webinar%20Presentation_Final.pdfUniversal Nasal Decolonization An Unexpected Solution to ...
Alcohol-based nasal antiseptic was selected for enhanced effects when compared to PVI and mupirocin: it does not stain, is clean and well tolerated by patients, ...
A Novel Protocol for Nasal Decolonization Using ...
Results: Patients receiving alcohol-based nasal decolonization had a lower rate of SSI compared with controls not receiving nasal decolonization ...
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