Status:
WITHDRAWN
Prophylactic Antibiotics for Surgical Site Infections and Beta-Lactam Allergy
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Surgical Site Infection
Beta-lactam Allergy
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Postoperative surgical site infection (SSI) is associated with unnecessary use of heath care resources including prolonged hospitalization and increased hospital readmission. Perioperative antibiotic ...
Detailed Description
In this prospective, randomized, single-blinded clinical trial, eligible subjects will be identified based on scheduled elective hysterectomy. Subjects with documented beta-lactam allergy in their cha...
Eligibility Criteria
Inclusion
- The subjects age 18 and older
- Subjects undergoing open total abdominal hysterectomy
- Subjects with documented beta-lactam allergy
Exclusion
- Subjects with documented anaphylaxis to Tier 1 or Tier 2 antibiotics
- Surgical procedure within 30 days prior to hysterectomy
- Robotic hysterectomy
- Presence of multidrug resistant organism such as methicillin-resistant Staphylococcus aureus (MRSA)
- Immunocompromised subject
- Cognitive deficits 7- Chronic Kidney Disease or patients on dialysis 8- Severe liver disease
Key Trial Info
Start Date :
August 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04401553
Start Date
August 16 2024
End Date
August 1 2026
Last Update
December 15 2023
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