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Prophylactic Antibiotics for Surgical Site Infections and Beta-Lactam Allergy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04401553
Recruitment Status : Not yet recruiting
First Posted : May 26, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.


Condition or disease Intervention/treatment Phase
Surgical Site Infection Beta-lactam Allergy Drug: cephalosporin Drug: Second tier antibiotic (Vancomycin) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: First Tier Versus Second Tier Antibiotics for Surgical Site Infections Following Hysterectomy In the Patients With a Beta-Lactam Allergy: A Prospective, Randomized, Single-Blinded Clinical Trial
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Antibiotics

Arm Intervention/treatment
Experimental: First Tier Antibiotic
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
First tier antibiotics, cephalosporin, will be given before anesthesia induction in the subjects with a history of allergy-like event to beta-lactam

Active Comparator: Second Tier Antibiotic
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)
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)
Other Name: Vancomycin




Primary Outcome Measures :
  1. Surgical site infections during early postoperative period [ Time Frame: Early post-operative period within a 30-day after hysterectomy ]
    Incidence of surgical site infections after hysterectomy


Secondary Outcome Measures :
  1. Infectious hospital readmission [ Time Frame: the postoperative period within a 90-days after hysterectomy ]
    Incidence of infectious hospital readmission



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subjects age 18 and older
  2. Subjects undergoing open or laparoscopic 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401553


Contacts
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Contact: Mark Haney, MD 214-648-6400 Mark.Haney@UTSouthwestern.edu
Contact: Emily Melikman, RN 214-645-7011 Emily.Melikman@UTSouthwestern.edu

Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Study Director: Seema Dave, MPH UT Southwestern Medical Center
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04401553    
Other Study ID Numbers: STU-2020-0317
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Hypersensitivity
Immune System Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Vancomycin
Cephalosporins
Anti-Infective Agents