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New treatment option for Surgical Site Infection
Official title Decolonization to Reduce After-Surgery Events of Surgical Site Infection
ClinicalTrials.gov ID: NCT05586776
What this study is testing
What is 4% Chlorhexidine Gluconate?
4% Chlorhexidine Gluconate is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for surgical site infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The DECREASE SSI Trial (Decolonization to Reduce After-Surgery Events of Surgical Site Infection) is a two-arm multi-center individual placebo-controlled randomized (2,700 participants randomized 1:1) clinical trial to reduce post-discharge surgical site infection following open colon or small bowel surgery by comparing chlorhexidine bathing plus nasal mupirocin in the 30 days following discharge to soap without antiseptic properties (placebo) and placebo nasal ointment. This trial seeks to enhance the care of the 675,000 patients annually who undergo colon and small bowel surgery by finding simple and efficacious interventions to reduce SSI.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older
- Recent open (not solely laparoscopic) surgery involving an abdominal incision within the past 14 days. For cesarean section, recruitment restricted...
- Able to communicate regularly by phone
- Able to bathe, shower or have this task performed by a caregiver
You likely can't join if
- Transfer to an acute care hospital
- Discharged to receive end-of-life hospice measures
- Discharged more than 14 days after surgery
- Allergic to mupirocin and/or chlorhexidine
- Active infection at enrollment\ \ Refers to
- Infections requiring systemic antibacterial agents, so viral illness (e.g., COVID, flu) is not an exclusion.
See the full eligibility criteria
- 18 years of age or older
- Recent open (not solely laparoscopic) surgery involving an abdominal incision within the past 14 days. For cesarean section, recruitment restricted to BMI ≥ 40.
- Able to communicate regularly by phone
- Able to bathe, shower or have this task performed by a caregiver
- Transfer to an acute care hospital
- Discharged to receive end-of-life hospice measures
- Discharged more than 14 days after surgery
- Allergic to mupirocin and/or chlorhexidine
- Active infection at enrollment\ \ Refers to
- Infections requiring systemic antibacterial agents, so viral illness (e.g., COVID, flu) is not an exclusion.
- Topical antibacterial agents do not count toward exclusion (e.g., topical products for acne)
- Prophylactic antibacterial agents do not count toward exclusion
- Surgical incision not closed at discharge
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Orange, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States; Orange, California, United States; Sacramento, California, United States; San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.