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

Surgical Site Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06378359
• Other study ID #: IDIM-2023-32364
• Status: Recruiting
• Start date: January 29, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Pragya Karki, MD
• Phone: 612-301-6316
• Email: pkarki[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Healthcare Associated Infections
• Infections
• Surgical Site Infections
• Surgical Wound Infection

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
• No screening for SA
All receive the 3 drug bundle, Nasal mupirocin, chlorhexidine gluconate (CHG) mouth rinse, and CHG body wash
• no screening
giving pre-surgical patients the three drug decolonization bundle without screening
• 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.
• 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

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center and Clinics	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy in eradicating Staphylococcus aureus (SA)	The study will compare the efficacy of four different decolonizing approaches and products in eradicating Staphylococcus aureus (SA) before surgery.	baseline