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The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement. A Pilot Randomized Controlled Trial
Sponsor: Ottawa Hospital Research Institute
Summary
Patients who undergo total ankle replacement surgery can sometimes develop problems with wound healing after their operation. These complications may include delayed healing, wound opening, or infection, which can lead to additional clinic visits, further surgery, and longer recovery times. Tranexamic acid (TXA) is a medication that has been used safely for many years in many types of surgery to reduce bleeding. Some studies suggest that it may also improve wound healing after foot and ankle surgery by reducing bleeding and swelling around the surgical site. However, there is not enough high-quality evidence to know whether TXA truly improves outcomes for patients undergoing total ankle replacement. This study is a pilot clinical trial designed to determine whether a larger study can be successfully carried out. Approximately 40 patients undergoing total ankle replacement surgery at The Ottawa Hospital will be randomly assigned to receive either TXA or a placebo (salt water solution). Neither the patients nor their health care team will know which treatment was given until the study is complete. All patients will receive standard surgical care and follow-up regardless of which group they are assigned to. Researchers will then collect information about wound healing, complications, additional surgeries, and infections at routine follow-up visits for up to six months after surgery. The outcomes will be compared between patients in each group. The results of this pilot study will help determine whether a larger clinical trial is feasible and may provide early information about whether TXA could improve recovery after total ankle replacement surgery. Ultimately, this research aims to improve patient outcomes and reduce complications following ankle replacement surgery.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-12
Completion Date
2027-12
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
Transexamic acid
Patients in the intervention group will receive 1.5g of TXA in 100ml normal saline (NS) solution. A second dose of 3g in 100ml NS of tranexamic acid will be given topically through a soaked sponge.
Normal Saline (0.9% NaCl)
Patients in the placebo group will receive 100ml normal saline (NS) solution intravenously. A second dose of 100ml normal saline will be given topically through a soaked sponge.
Locations (1)
The Ottawa Hospital Civic Campus
Ottawa, Ontario, Canada