Topical Antibiotics in Surgical Site

February 13, 2024 updated by: Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

Use of Topical Broad-spectrum Antibiotics as a Prophylaxis for Surgical Site Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Despite the improvement in the ankle fracture management, it has been estimated that the ankle fracture incidence has been increasing and one of the motives is an increase of ageing population. It has been estimated that ankle fractures have an incidence between 71 to 187 cases per 100,000 inhabitants a year.

Most of the ankle fractures are due to fallings or traffic accidents, it has been reported that up to 71% from ankle fracture causes are due to mechanisms of low energy, especially among the elderly and those with comorbidities these injuries are commonly caused by the inversion of the ankle, where the force and weight of the body falls in the fibula, which in young individuals usually results in only an ankle sprain, being the conservative management the most effective treatment. Nevertheless, in aging patients, these same mechanisms can provoke a fracture.

Ankle fractures represent a challenge for the orthopedic surgeon because in this very joint, despite being relatively stable, rests the entire bodyweight and a correct approach is required for the functionality to not being affected.

Ankle fractures are classified according to AO/OTA and Danis-Weber classifications. Single malleolus fractures are the most frequent (43.7 - 10%) and inside the Orthopedic Trauma Association (OTA) classification, type B are more common with a 65.8%, which tend to be displaced fractures. In patients with unstable or displaced fractures, or where a severe dislocation exists, surgical intervention is advised.

These injuries require a surgical treatment, which brings another issue: surgical site infections.

Surgical site infections can be divided according to the 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.

Deep incisional surgical site infections are defined as:

  1. An infection that occurs within the next 30 days after the surgery if no implant is there or a year after the surgery if there is an implant and the infection seems to be related with the procedure, where involves the deep tissue as fascial and muscular layers and presents:

    1. Purulent drainage from the deep incision
    2. Surgical incision that opens spontaneously or deliberately opened by a surgeon, and a positive culture
  2. If there is no positive culture, the presence of fever (> 38° Celsius degrees), pain or tenderness.
  3. An abscess or a diagnosis made by a surgeon or the attending medic. There are established risk factors for the development of surgical site infections, some of them are patient age, nutritional state, diabetes, smoking, obesity, altered immune state (8) and bacteria colonization due to contamination. This is relevant because S. aureus, negative coagulase Staphylococcus or Enterococcus are the most common causal agents for surgical site infections, which tend to be multiresistant to the most used antibiotics.

There is controversy in the prophylactic usage of antibiotics in the management of surgical injuries. The available literature supports the usage of prophylactic IV antibiotics 1 hour prior procedure and until 48 hours after, as defined by lead surgeon. Other prophylactic management is the usage of topical broad-spectrum antibiotics.

The information about the usage of topical broad-spectrum antibiotics is equally controversial. Topical vancomycin is advised in patients with surgeries that involve a high risk of developing severe and resistant infections such as spine, thorax, or cranium surgery, where its application has shown a decrease of surgical site infection acquisition risk. In one study, topical antibiotic application was carried out by irrigating 2.5 g of Vancomycin dissolved in 2 mL of saline solution before sternum incision, and at the procedure ending after injury closure. In some other studies 1 g of Vancomycin powder was placed over the cranium, then irrigated with saline solution before injury closure.

Nevertheless, these prophylaxis therapy has not been evaluated in patients under open ankle surgery with intern fixation. The available literature about these patients' management doesn´t oppose to the general surgical site infection guidelines.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • NL
      • Monterrey, NL, Mexico, 64460
        • Hospital Universitario "Dr. José E. González"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Nuevo Leon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Actual)

December 21, 2023

Study Completion (Actual)

February 12, 2024

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 6, 2022

Study Record Updates

Last Update Posted (Estimated)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OR20-00007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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