Clinical trial NCT05363462: Topical Antibiotics in Surgical Site
Official title: Use of Topical Broad-spectrum Antibiotics as a Prophylaxis for Surgical Site Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Complication of Surgical Procedure
Keywords: Antibiotic
Surgical site infection
Ankle fractures
Complication
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of treatment with a surgical ankle fracture

1. Surgical treatment
2. Surgical treatment plus 1 g of topical vancomycin
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Rate of surgical infection site
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. José E. González"
state: NL
Study officials:
References:
citation: Juto H, Nilsson H, Morberg P. Epidemiology of Adult Ankle Fractures: 1756 cases identified in Norrbotten County during 2009-2013 and classified according to AO/OTA. BMC Musculoskelet Disord. 2018 Dec 13;19(1):441. doi: 10.1186/s12891-018-2326-x.
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