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Antiseptic Decolonization for Surgical Site Infections (DECREASE SSI Trial)
Phase 4
Recruiting
Led By Susan Huang, MD, MPH
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of hospital discharge
Awards & highlights
DECREASE SSI Trial Summary
This trial seeks to improve care for 675,000 patients who have colon/small bowel surgery each year by finding simple, effective ways to reduce surgical site infections.
Who is the study for?
This trial is for adults who've had recent open surgery on their colon or small bowel, can bathe themselves or have help doing so, and are able to talk on the phone. It's not for those with an active infection at enrollment, unclosed surgical incisions, transferred to acute care hospitals post-surgery, discharged more than 14 days after surgery, in end-of-life hospice care, or allergic to mupirocin/chlorhexidine.Check my eligibility
What is being tested?
The DECREASE SSI Trial is testing if bathing with chlorhexidine and using nasal mupirocin for 30 days after discharge can reduce infections compared to using regular soap (placebo) and placebo nasal ointment in patients who've undergone certain bowel surgeries.See study design
What are the potential side effects?
Possible side effects may include skin reactions like rash or irritation from chlorhexidine use and potential local irritation or allergic reactions from mupirocin. The placebos are expected to have minimal risk of side effects.
DECREASE SSI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days of hospital discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of hospital discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to First Post-Discharge Surgical Site Infection
DECREASE SSI Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: DecolonizationActive Control2 Interventions
Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).
Group II: Routine CarePlacebo Group2 Interventions
Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.
Find a Location
Who is running the clinical trial?
University of California, San FranciscoOTHER
2,506 Previous Clinical Trials
15,235,855 Total Patients Enrolled
University of California, DavisOTHER
911 Previous Clinical Trials
4,706,819 Total Patients Enrolled
University of California, IrvineLead Sponsor
544 Previous Clinical Trials
1,920,343 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can bathe myself or have someone to help me.I am 18 years old or older.I do not have an active infection needing antibiotics at enrollment.I can make regular phone calls.I was discharged from the hospital more than 14 days ago after surgery.I had recent open surgery involving my abdomen or a C-section with a BMI ≥ 40.I have been moved to a hospital for immediate, intensive care.
Research Study Groups:
This trial has the following groups:- Group 1: Decolonization
- Group 2: Routine Care
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Decolonization procedure been validated by the FDA?
"There is a substantial amount of evidence proving the efficacy and safety of Decolonization, leading to its rating of 3 on our scale."
Answered by AI
Are there still available slots for participants in this clinical trial?
"This trial, which was initially posted on January 1st 2023 and last updated on October 15th 2022, is not actively recruiting. However, there are 800 other studies currently accruing patients throughout the country."
Answered by AI
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