Prophylactic Antibiotics for Surgical Site Infections and Beta-Lactam Allergy

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Anti-Bacterial Agents; Cephalosporins; Vancomycin

Criteria

Inclusion Criteria:

1. The subjects age 18 and older

2. Subjects undergoing open total abdominal hysterectomy

3. Subjects with documented beta-lactam allergy

Exclusion Criteria:

1. Subjects with documented anaphylaxis to Tier 1 or Tier 2 antibiotics

2. Surgical procedure within 30 days prior to hysterectomy

3. Robotic hysterectomy

4. Presence of multidrug resistant organism such as methicillin-resistant Staphylococcus aureus (MRSA)

5. Immunocompromised subject

6. Cognitive deficits 7- Chronic Kidney Disease or patients on dialysis 8- Severe liver disease