Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients

• ClinicalTrials.gov Identifier: NCT06378359
• Recruitment Status: Recruiting
• First Posted: April 22, 2024
• Last Update Posted: April 22, 2024
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Tracking Information

• First Submitted Date: April 18, 2024
• First Posted Date: April 22, 2024
• Last Update Posted Date: April 22, 2024
• Actual Study Start Date: January 29, 2024
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2024)

Efficacy in eradicating Staphylococcus aureus (SA) [ Time Frame: baseline ]

The study will compare the efficacy of four different decolonizing approaches and products in eradicating Staphylococcus aureus (SA) before surgery.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
• Official Title: Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients

Brief Summary

The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent.

The study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap.

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 SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: The study will recruit patients from outpatient surgical clinics at the time their surgical procedures are planned. The study team will work with collaborating surgeons at UMMC to identify these patients. The study will recruit the following NIH priority populations: low income groups, minority groups, women, the elderly and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care. These patients will be part of the surgical clinics' patient population and will be approached to participate in the study at the time their surgery is planned with their surgeon.

Condition

• Staphylococcus Aureus Colonization
• Surgical Site Infections
• Healthcare Associated Infections

Intervention

• Other: Screening and decolonization for SA carriers with the 3 drug bundle
  nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse and CHG soap showers x 5 days and non-SA carriers receive 2 CHG pre-op showers
• Other: No screening for SA
  All receive the 3 drug bundle, Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
• Other: no screening
  giving pre-surgical patients the three drug decolonization bundle without screening
• Other: Nasal povidone-iodine 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.
• Other: Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening
  Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening

Study Groups/Cohorts

• Arm 1a
  screening for SA carriage and using the three-drug decolonization bundle among patients with SA colonization
  Intervention: Other: Screening and decolonization for SA carriers with the 3 drug bundle
• Arm 1b
  non SA carriers in this arm will get two pre-op showers with an antiseptic soap
  Intervention: Other: No screening for SA
• Arm 2

  giving pre-surgical patients the three drug decolonization bundle without screening.

  Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash

  Intervention: Other: no screening
• Arm 3
  giving pre-op nasal povidone iodine without screening
  Intervention: Other: Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening.
• Arm 4
  giving nasal alcohol gel without screening
  Intervention: Other: Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 18, 2024): 250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2026
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Eligible participanst are outpatients in orthopedic, urology, neuro, otolaryngology, plastic and general surgery and OB/GYN clinics who are scheduled to undergo surgery at participating trial sites.
• Anticipated surgery ≥ 10 days after the date of enrollment, to allow time for completion of baseline cultures and the decolonization protocol.
• Age ≥ 18 years
• Ability to complete the decolonization protocol pre-operatively as an outpatient.
• No antibiotic therapy at the time of, or seven days prior to, baseline cultures, and no subsequent antibiotic therapy prior to the surgical procedure. Standard pre-op antibiotic prophylaxis given.
• Patients are having skin incisions as part of their scheduled surgical procedure.

Exclusion Criteria:

• Inability to give informed consent
• Surgery anticipated <10 days after the baseline cultures

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Pragya Karki, MD; 612-301-6316; pkarki@umn.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06378359
• Other Study ID Numbers: IDIM-2023-32364
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Minnesota
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Minnesota
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Susan Kline, MD, MPH; University of Minnesota

• PRS Account: University of Minnesota
• Verification Date: April 2024