Restricted or Liberal Antibiotics After Appendectomy - Denver Health

Last updated: July 17, 2024
Sponsor: Denver Health and Hospital Authority
Overall Status: Active - Recruiting

Phase

N/A

Condition

Appendicitis

Treatment

Restricted Duration of SOC Antibiotic Use

Liberal Duration of SOC Antibiotic Use

Clinical Study ID

NCT05002829
20191238
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to see if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Planned appendectomy (laparoscopic or open) for simple or complicated (perforated organgrenous) appendicitis

  • Working telephone number or reliable method to contact patient after hospitaldischarge

Exclusion

Exclusion Criteria:

  • Unable to consent

  • Pregnant Women

  • Prisoners

  • Immunocompromised as determined by clinical team, or patients actively receivingsteroids, chemotherapy, or immunosuppressing medications (for example tacrolimus),or patients with active hematologic malignancy affecting the immune system,leukopenia, or end-stage AIDS

  • Heart failure

  • Allergy to bupivacaine

  • Unlikely to comply with treatment or follow-up

  • Inpatient consultation for appendicitis

  • Clinically suspected of sepsis based on Sepsis-3 definition

  • Current use of antibiotics for other indications

  • Uncontrolled hyperglycemia or Type 1 Diabetes

  • Surgeon preference

  • Patient preference

  • Research team unavailable

Study Design

Total Participants: 2275
Treatment Group(s): 2
Primary Treatment: Restricted Duration of SOC Antibiotic Use
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • University of California san Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • Denver Health and Hospital Authority

    Denver, Colorado 80204-4507
    United States

    Active - Recruiting

  • Ryder Trauma Center / Jackson Memorial Hospital

    Miami, Florida 33101
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • NYU Langone Brooklyn

    Brooklyn, New York 11220
    United States

    Site Not Available

  • NYU Langone Manhattan

    New York, New York 10016
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Atrium Health Cabarrus

    Concord, North Carolina 28025
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center

    El Paso, Texas 79905
    United States

    Site Not Available

  • Texas Health Resources

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Inova

    Falls Church, Virginia 22042
    United States

    Site Not Available

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