Topical Antibiotics in Ankle Fracture Surgery (TAAFS) pilot study

Phase 3

• Conditions: ankle fracture; surgical site infection; Surgery - Surgical techniques; Musculoskeletal - Other muscular and skeletal disorders; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12621001655831
• Lead Sponsor: Dr William O'Callaghan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-01
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 332

Inclusion Criteria

Patients aged 18 and older
Injury meeting the following criteria:
a.Open or Closed Ankle Fracture
b.Definitively treated with plate and screw fixation

Exclusion Criteria

•Patients with fractures that have evidence of active infection (fracture related infection) or have evidence of systemic infection or sepsis (chest infection, urinary traction infection or similar) or other unrelated orthopaedic infection such as a prosthetic joint or chronic musculoskeletal infection for which they are currently on treatment for
•Patients with adjacent fractures to the same limb – tibia pilon, tibial shaft, talus, or mid foot fractures requiring operative intervention
•Patients with bilateral ankle injuries due to the risk of systemic antibiotic toxicity from dual dosage and confounding of placebo results
•Patients with a subsequent injury who have previously been enrolled in the study for the contralateral limb
•Patients with periprosthetic ankle fractures with existing orthopaedic implants
•Patients with open G3 Gustilo-Anderson injuries who will not undergo primary coverage or closure at the time of fixation and will have such treatment scheduled for a subsequent procedure date
•Patients who have already had definitive fixation before enrollment in the trial
•Patients with an allergy or history of adverse drug reaction to vancomycin
•Patient with an allergy or history of adverse drug reaction to gentamicin
•Patients who are currently pregnant
•Patients who are do not speak English
•Patients who are incarcerated
•Patients who are determined by the local investigators to have severe difficulties in maintaining follow-up for the following reasons:
oDiagnosis of a severe psychiatric disorder that is not adequately controlled
oPatients without capacity or lack family support to participate in follow-up
oPatients living remote from the study site who are unable to be followed up at any of the study sites
oPatients who are homeless without adequate contact information to facilitate follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified