The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement. A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
This study is a randomized, double-blind, placebo-controlled pilot trial designed to determine the feasibility of conducting a definitive multicentre randomized controlled trial evaluating intravenous and topical tranexamic acid (TXA) for reducing postoperative wound complications following primary total ankle replacement (TAR). The trial will also collect preliminary safety and clinical outcome data to estimate the potential effect of TXA on postoperative wound complications.
Patients with ankle arthritis scheduled to undergo primary TAR will be screened for eligibility and enrolled after providing informed consent. Participants will be randomized in a 1:1 ratio to receive either intravenous and topical TXA or placebo (normal saline) administered according to the study protocol. Participants, treating surgeons, clinical staff, outcome assessors, and investigators will remain blinded to treatment allocation throughout the study.
All participants will undergo standard perioperative management and postoperative care as determined by their treating surgeon. Follow-up assessments will occur according to the routine postoperative schedule through six months after surgery. Data collected will include participant demographics, medical history, operative characteristics, study drug compliance, adverse events, and clinical outcomes.
The primary objective of this pilot trial is to determine the feasibility of conducting a definitive multicentre randomized controlled trial. Feasibility outcomes include participant recruitment, protocol adherence, treatment compliance, retention, completeness of follow-up, and completeness of outcome data collection.
Secondary objectives are to obtain preliminary estimates of the effect of intravenous TXA on postoperative wound complications and other clinically relevant outcomes, including surgical site infection, reoperation, blood transfusion, thromboembolic events, hospital readmission, and patient-reported outcome measures. Safety outcomes, including adverse events and serious adverse events, will also be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
TXA
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.
干预措施: Transexamic acid (Drug)
Placebo
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.
干预措施: Normal Saline (0.9% NaCl) (Drug)
结局指标
主要结局
Recruitment rate
时间窗: 12 months
The primary feasibility outcome measure of the pilot trial is the overall recruitment rate based on the total recruitment over 12 months
次要结局
- Treatment Fidelity(6 months)
- Retention Rate(6 months)
- Consent Rate(12 months)
- Trial Implementation Barriers(12 months)
- Wound Complications(6 months)
- Re-operation Rate(6 months)
- Prosthetic Joint Infection(6 months)
- Venous Thromboembolism(6 months)