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Prophylactic Antibiotics for Surgical Site Infections and Beta-Lactam Allergy

NCT04401553 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-12-15

No results posted yet for this study

Summary

Postoperative surgical site infection (SSI) is associated with unnecessary use of heath care resources including prolonged hospitalization and increased hospital readmission. Perioperative antibiotic prophylaxis is one of the most important strategies for prevention of SSI. If there is a beta-lactam allergy, second tier antibiotics (vancomycin and clindamycin) are recommended alternatives to first- and second-generation cephalosporins because of fears of possible allergy.

This prospective, randomized, and single-blinded clinical trial is designed to examine causality between second tier antibiotics use and surgical site infections in the subjects with a documented unverified penicillin allergy. Unverified beta-lactam allergy could be associated with antimicrobial treatment failure with second tires antibiotics during postoperative period.

Conditions

  • Surgical Site Infection
  • Beta-lactam Allergy

Interventions

DRUG

cephalosporin

First tier antibiotics, cephalosporin, will be given before anesthesia induction in the subjects with a history of allergy-like event to beta-lactam

DRUG

Second tier antibiotic (Vancomycin)

Second tier antibiotics, vancomycin, will be given before anesthesia induction for infection prevention in the subjects with a history of allergy-like event to beta-lactam (standard of care)

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Mark Haney, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-16
Primary Completion
2026-08-31
Completion
2026-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04401553 on ClinicalTrials.gov