The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement. A Pilot Randomized Controlled Trial

NCT07828262 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 4224
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankle Arthritis; Wound Complication

Keywords

ankle replacement; wound infection; total ankle arthroplasty; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  The primary feasibility outcome measure of the pilot trial is the overall recruitment rate based on the total recruitment over 12 months

  12 months

Secondary Outcomes (8)

• Treatment Fidelity

  6 months

• Retention Rate

  6 months

• Consent Rate

  12 months

• Trial Implementation Barriers

  12 months

• Wound Complications

  6 months

Study Arms (2)

TXA

EXPERIMENTAL

Patients will receive 1.5g of TXA in 100ml normal saline (NS) solution intravenously within our hour prior to skin incision, and prior to tourniquet inflation. A second dose of 3g in 100ml NS of tranexamic acid will be given topically through a soaked sponge after implant placement and prior to closure. This will be left in place for five minutes.

Drug: Transexamic acid

Placebo

PLACEBO COMPARATOR

Patients will receive either 100ml normal saline (NS) solution intravenously within our hour prior to skin incision, and prior to tourniquet inflation. Then, a 100ml normal saline solution will be given topically through a soaked sponge after implant placement and prior to closure. This will be left in place for five minutes.

Drug: Normal Saline (0.9% NaCl)

Interventions

Transexamic acid DRUG

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.

TXA

Normal Saline (0.9% NaCl) DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing either primary or revision ankle replacement surgery
• Patient is considered to benefit from surgical management at the treating surgeon's discretion
• The patient is willing and able to provide written informed consent
• The patient is willing and able to comply with post-operative rehabilitation protocols and all follow-up visits

You may not qualify if:

• Pregnant or breastfeeding patient
• Uncontrolled diabetes (HgbA1C \> 8)
• Known allergy or contraindication for tranexamic acid use including: presence of coronary stents, cerebrovascular event in the last six months, known thromboembolic disorder, hepatic dysfunction, impaired renal clearance, medications with known drug interactions\*\*\*
• Lateral-based ankle replacement system
• Patient receiving anticoagulation therapy
• Investigator concerns about study compliance
• Medically unfit for surgery or anesthetic
• Acquired color vision problems that are not genetics
• There are potential drug-drug interactions leading to myocardial infarction after coadministration of tranexamic acid with hormonal contraceptives, hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine, or nitroglycerin. Therefore, patients on these medications will be excluded.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Wound Infection

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bradley Meulenkamp, MD MSc FRCSC

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator, MSc

CONTACT

6137378899; hghaziasgar@ohri.ca

Clinical Research Coordinator, BSc

CONTACT

marleclerc@ohri.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)