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Topical Antibiotics in Surgical Site

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ClinicalTrials.gov Identifier: NCT05363462
Recruitment Status : Recruiting
First Posted : May 6, 2022
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

Study Description
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Brief Summary:

Ankle fractures are one of the most common injuries in traumatology. It is the fourth most common fracture in general population after hip, wrist, and hand fractures. These injuries are the second cause of hospitalization due to fractures.

Surgical site infections can be divided according to the Center of Disease Control (CDC) in superficial surgical site infections whose are defined as any infection that happens within the next 30 days after the procedure, they involve only the skin and subcutaneous tissue of the incision, and the patient presents at least one of the following: purulent drainage of the superficial incision, microorganisms isolation from an aseptically obtained culture of body fluid or tissue or the pain existence, tenderness or local inflammation at the superficial incision site despite negative cultures. Also, a diagnosis made by the surgeon or attending medic.


Condition or disease Intervention/treatment Phase
Surgical Site Infection Complication of Surgical Procedure Drug: Vancomycin 1000 MG Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two groups of treatment with a surgical ankle fracture

  1. Surgical treatment
  2. Surgical treatment plus 1 g of topical vancomycin
Masking: Single (Participant)
Masking Description: The patients involved in the protocol will be blinded
Primary Purpose: Prevention
Official Title: Use of Topical Broad-spectrum Antibiotics as a Prophylaxis for Surgical Site Infection
Actual Study Start Date : January 5, 2022
Estimated Primary Completion Date : December 21, 2022
Estimated Study Completion Date : March 12, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ankle fracture surgical treated plus 1 g of topical vancomycin
A standard surgical treatment of patients with ankle fracture must be carried out. Classified according to Danis Webber classification system. Plus application of 1 g of vancomycin in powder in the surgical site
 Drug: Vancomycin 1000 MG
Application of vancomycin in powder in the surgical site of treatment before closure of surgical wound
Other Names:
  • antibiotic
  • vancomycin
Active Comparator: Ankle fracture surgical treated
A standard surgical treatment of patients with ankle fracture must be carried out. Classified according to Danis Webber classification system
 Drug: Vancomycin 1000 MG
Application of vancomycin in powder in the surgical site of treatment before closure of surgical wound
Other Names:
  • antibiotic
  • vancomycin


Outcome Measures
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Primary Outcome Measures :
  1. Rate of surgical infection site [ Time Frame: 90 days ]
    Defined as the number of patients with surgical infection site from the total of evaluated patients included in each group.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Patients older than 18 years

    • Patients with a closed fracture independently of mechanism and classification
    • Patients who require an open reduction with internal fixation surgery
    • Patients who decide to participate in the study

Exclusion Criteria:

  • Patients with exposed fractures
  • Presence of any form of immune deficiency
  • Vancomycin hyper sensibility
  • Surgery in the affected ankle within the last six months
  • Steroid usage
  • Antibiotic usage one week prior entry
Contacts and Locations
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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): NCT05363462


Contacts
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Contact: Jose Gerardo Garza-Leal, PhD 528183294000 ext 2870 investigacionclinical@meduanl.com

Locations
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Mexico
Hospital Universitario "Dr. José E. González" Recruiting
Monterrey, NL, Mexico, 64460
Contact: Carlos Acosta-Olivo, PhD    8183467798    dr.carlosacosta@gmail.com   
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
More Information
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Publications of Results:

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Responsible Party: Carlos A Acosta-Olivo, Professor, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT05363462    
Other Study ID Numbers: OR20-00007
First Posted: May 6, 2022    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon:
Antibiotic
Surgical site infection
Ankle fractures
Complication
Additional relevant MeSH terms:
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Infections
Surgical Wound Infection
Pathologic Processes
Wound Infection
 Postoperative Complications
Anti-Bacterial Agents
Vancomycin
Anti-Infective Agents