Topical Antibiotics in Surgical Site
Condition: Surgical Site Infection; Complication of Surgical Procedure
MeSH terms: Infections; Surgical Wound Infection
Study type: Interventional

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.
    

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.
    

Intervention name(s): Vancomycin 1000 MG
Intervention type(s): Drug
Intervention description(s): Application of vancomycin in powder in the surgical site of treatment before closure of surgical wound
Other intervention name(s): antibiotic; vancomycin
Intervention MeSH terms: Anti-Bacterial Agents; Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups of treatment with a surgical ankle fracture
Surgical treatment
Surgical treatment plus 1 g of topical vancomycin
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Antibiotic; Surgical site infection; Ankle fractures; Complication