None listed
Conditions
Brief summary
The proposed pilot study is a multi-center, prospective, double-blinded, randomized controlled trial comparing standard surgical fixation of ankle fractures with and without local topical antibiotics at the time of wound closure. The null hypothesis is that there will be no difference in post-operative rates of infection despite the addition of local topical antibiotics to the surgical wound at the time of closure. We will test our hypothesis by randomizing one group of patients to receive topical vancomycin and gentamicin solution to the wound at the time of closure and the other group to not receive additional topical antibiotics. Routine follow-up of patients will be completed under the standard of care, to assess whether or not the addition of topical antibiotics at the time of wound closure will reduce the rate of post-operative wound infection in ankle fracture surgery.
Interventions
To evaluate whether the addition of topical antibiotics (vancomycin and gentamicin) at the time of wound closure reduces surgical site infection in ankle fracture surgery.
Patients randomized to the intervention arm will receive local antibiotics. The first of these two groups will receive 1000 mg of sterile vancomycin powder mixed with 160 mg gentamicin liquid (80mg per 2mls solution), forming a 4ml antibiotic solution. The scrub nurse mixes the 1000 mg of powdered vancomycin with the 160 mg g
To evaluate whether the addition of topical antibiotics (vancomycin and gentamicin) at the time of wound closure reduces surgical site infection in ankle fracture surgery. Patients randomized to the intervention arm will receive local antibiotics. The first of these two groups will receive 1000 mg of sterile vancomycin powder mixed with 160 mg gentamicin liquid (80mg per 2mls solution), forming a 4ml antibiotic solution. The scrub nurse mixes the 1000 mg of powdered vancomycin with the 160 mg gentamicin liquid (formulation comes as 80 mg/2ml). This makes a 4 ml clear thickened fluid which is then drawn up into a 5ml syringe. A 25g needle is then applied to the syringe, and the antibiotic solution can then be directly applied into the wound following fixation and final saline irrigation, but prior to wound closure. If multiple wounds are present, as in the case of bi/tri-malleolar fracture fixation, then the solution will be divided between the wounds in proportions equal to the relative wound sizes as per the surgeon’s clinical judgement. The solution will not be used for percutaneous single screw or reduction clamp incisions. Surgeons are to place the solution directly into the deep portion of the wound onto exposed metalwork, and are not to alter the solution in any way prior to its application. Duration of the surgical procedure will vary and depend on fracture type, complexity and surgeon operative speed. Typically ankle fracture surgery takes between 45min and 2hrs. The surgical wound is closed in a standard fashion and will be at the discretion of the surgeon. Wound closure should be in layers and aim to be watertight, with deeper layers being closed typically with absorbable 1-0/2-0/3-0 Vicryl, PDS, or Monocryl. Skin is usually closed with either 3-0/4-0 nylon, Prolene, or Monocryl.
Sponsors
Dr William O'Callaghan
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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: o Diagnosis of a severe psychiatric disorder that is not adequately controlled o Patients without capacity or lack family support to participate in follow-up o Patients living remote from the study site who are unable to be followed up at any of the study sites o Patients who are homeless without adequate contact information to facilitate follow-up
Outcome results
None listed