The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement. A Pilot Randomized Controlled Trial (TXA in TAR)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
The results of this pilot study will inform the design and implementation of a future adequately powered multicentre randomized controlled trial evaluating the effectiveness of intravenous TXA in improving outcomes following total ankle replacement.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Clinical Research Coordinator, MSc
- Numéro de téléphone: 19217 6137378899
- E-mail: hghaziasgar@ohri.ca
Sauvegarde des contacts de l'étude
- Nom: Clinical Research Coordinator, BSc
- E-mail: marleclerc@ohri.ca
Lieux d'étude
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4E9
- The Ottawa Hospital Civic Campus
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Contact:
- Clinical Research Coordinator
- Numéro de téléphone: 19217 6137378899
- E-mail: hghaziasgar@ohri.ca
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Comparateur placebo: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recruitment rate
Délai: 12 months
|
The primary feasibility outcome measure of the pilot trial is the overall recruitment rate based on the total recruitment over 12 months
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Treatment Fidelity
Délai: 6 months
|
A secondary feasibility outcome of the pilot trial is treatment fidelity, defined by adherence to study drug assignment and pilot trial protocol over 6 months of study involvement.
|
6 months
|
|
Retention Rate
Délai: 6 months
|
A secondary feasibility outcome of the pilot trial is retention rate, defined by participant completion of the pilot trial protocol over 6 months follow-up.
|
6 months
|
|
Consent Rate
Délai: 12 months
|
A secondary feasibility outcomes of the pilot trial include is consent rates for eligible participants who are approached over 12 months, including reasons for non-consent.
|
12 months
|
|
Trial Implementation Barriers
Délai: 12 months
|
A secondary feasibility outcome of the pilot trial is trial implementation barriers.
These include data capture and study management barriers, study team infrastructure challenges, participant- and site-level challenges, intervention-related challenges, and longitudinal study design challenges.
Outcomes categorized as not requiring major protocol changes, minor amendable protocol changes, or significant design/safety concerns.
|
12 months
|
|
Wound Complications
Délai: 6 months
|
A secondary clinical outcome measure, to be studied further in the definitive trial, is wound complications.
Wounds will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months.
Each wound will be given a grade from zero to seven, as defined by the Foot and Ankle Postoperative Wound Classification scheme by Schipper et al.
Wounds will be graded by two different assessors.
|
6 months
|
|
Re-operation Rate
Délai: 6 months
|
A secondary clinical outcome measure, to be studied further in the definitive trial, is re-operation rate.
Relevant re-operations included will be for any subsequent surgery related to the TAR procedure, including wound-related debridement, prosthetic revision surgery (including any component revision) and others.
Re-operations within 6 months of primary surgery will be included.
|
6 months
|
|
Prosthetic Joint Infection
Délai: 6 months
|
A secondary clinical outcome measure, to be studied further in the definitive trial, is prosthetic joint infections.
Prosthetic joint infection will be defined as any infection that is confirmed by culture swab and treated with antibiotics.
Infections will be subdivided into superficial infections (swab positive superficial to fascia) and deep infections (swab positive in direct contact with the prosthesis).
Infections will be included up to 6 months from primary surgery.
|
6 months
|
|
Venous Thromboembolism
Délai: 6 months
|
VA secondary clinical outcome measure, to be studied further in the definitive trial, is venous thromboembolism (VTE) events.
VTE events will be captured based on confirmation on investigation with either lower extremity doppler ultrasound for lower extremity deep vein thrombosis, or chest helical CT or ventilation/perfusion scan for investigation for pulmonary embolism.
Events will be included within 6 months of primary surgery.
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Bradley Meulenkamp, MD MSc FRCSC, The Ottawa Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 4224
Plan pour les données individuelles des participants (IPD)
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