Prophylactic Antibiotics for Surgical Site Infections and Beta-Lactam Allergy

NCT04401553 | Withdrawn Phase 4

• 1 other identifier: STU-2020-0317
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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

Outcome Measures

Primary Outcomes (1)

• Surgical site infections during early postoperative period

  Incidence of surgical site infections after hysterectomy

  Early post-operative period within a 30-day after hysterectomy

Secondary Outcomes (1)

• Infectious hospital readmission

  the postoperative period within a 90-days after hysterectomy

Study Arms (2)

First Tier Antibiotic

EXPERIMENTAL

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

Drug: cephalosporin

Second Tier Antibiotic

ACTIVE COMPARATOR

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

Drug: Second tier antibiotic (Vancomycin)

Interventions

cephalosporin DRUG

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

First Tier Antibiotic

Second tier antibiotic (Vancomycin) DRUG

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)

Also known as: Vancomycin

Second Tier Antibiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects age 18 and older
• Subjects undergoing open total abdominal hysterectomy
• Subjects with documented beta-lactam allergy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cephalosporins; Vancomycin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mark Haney, MD

  University of Texas Southwestern Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: August 16, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 15, 2023

Record last verified: 2023-12