Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) - Atrium Health
NCT ID: NCT05746520
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
268 participants
INTERVENTIONAL
2023-03-02
2025-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Restricted Post-Operative Antibiotics Group
Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics.
Participants undergoing standard of care (SOC) with complicated (gangrenous or perforated) appendicitis will receive 24 hours of SOC post-operative antibiotics.
Antibiotic
Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.
Restricted Duration of SOC Antibiotic Use
Use of Standard of Care Antibiotics, type as determined by the clinician, will be restricted to none or 24 hours of post-operatively.
Antibiotic
Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.
Liberal Post-Operative Antibiotics Group
Participants undergoing standard of care (SOC) with simple appendicitis will receive 24 hours of post-operative antibiotics.
Participants undergoing standard of care (SOC) with complicated (gangrenous or perforated) appendicitis will receive 4 days of SOC post-operative antibiotics.
Antibiotic
Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.
Liberal Duration of SOC Antibiotic Use
Use of Standard of Care Antibiotics, type as determined by the clinician, will be permitted for 24 hours or 4 days of post-operatively.
Antibiotic
Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.
Interventions
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Antibiotic
Type of antibiotic is per clinical judgement with the duration being the experimental aspect of this study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned appendectomy (laparoscopic or open)
* Willing and able to provide informed consent
* Working telephone number or reliable method to contact patient after hospital discharge
Exclusion Criteria
* Pregnant Women
* Prisoners
* immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage Acquired immunodeficiency syndrome (AIDS)
* Heart Failure
* Allergy to Bupivacaine
* Unlikely to comply with treatment or follow-up
* Inpatient consultation for appendicitis
* Clinically suspected sepsis based on Sepsis-3 definition
* Current use of antibiotics for other indications
* Type 1 Diabetes or uncontrolled hyperglycemia
18 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Rafael Torres Fajardo, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IRB00086118
Identifier Type: -
Identifier Source: org_study_id
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