Decolonization to Reduce After-Surgery Events of Surgical Site Infection (DECREASE SSI)

University of California Irvine (UCI)

Status and phase: Enrolling; Phase 4

Conditions: Surgical Site Infection

Treatments: Drug: Soap Without Antiseptic Properties (Placebo); Drug: 4% Chlorhexidine Gluconate; Drug: 2% Mupirocin; Drug: Placebo Nasal Ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT05586776

1304

Details and patient eligibility

About

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.

Enrollment: 2,700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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

Exclusion criteria

• 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

  1. Infections requiring systemic antibacterial agents, so viral illness (e.g., COVID, flu) is not an exclusion.
  2. Topical antibacterial agents do not count toward exclusion (e.g., topical products for acne)
  3. Prophylactic antibacterial agents do not count toward exclusion

• Surgical incision not closed at discharge

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,700 participants in 2 patient groups, including a placebo group

Decolonization

Active Comparator group

Description:

Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).

Treatment:

Drug: 2% Mupirocin

Drug: 4% Chlorhexidine Gluconate

Routine Care

Placebo Comparator group

Description:

Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.

Treatment:

Drug: Placebo Nasal Ointment

Drug: Soap Without Antiseptic Properties (Placebo)