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Hand edema following hand surgery is a common yet devastating side effect that can lead to early stiffness, prolonged rehabilitation and diminished function. These factors can reduce a patient's quality of life; mounting to an overall delay in recovery, return to work and daily activities. Conventional edema therapy includes cryotherapy, external compression, active and passive exercises and various types of massage. However, there is little evidence to suggest these modalities are effective. Tranexamic acid (TXA) is an antifibrinolytic that has been used in surgical disciplines for decades to aid in reducing intraoperative blood loss and consequent transfusions. Recently, the use of TXA for curbing post-operative edema and ecchymosis has shown promising results, however, its use in hand surgery has not been studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid (TXA) | Experimental | Patients in the TXA arm will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before their surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after the first dose on the day of their surgery |
|
| Standard of Care (SOC) | Placebo Comparator | Patients in the (SOC) arm will receive 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) before their surgery and 50cc of IV Placebo (standard intravenous normal saline fluid - 0.9% sodium chloride) 3-6 hours after the first dose on the day of their surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Patients will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before your surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after your first dose on the day of your surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to protocol | Assess number of patients who receive hand volume measurements at all designated time intervals. The outcome goal will be 90% | 12 weeks |
| Treatment Completion Rate | Asses proportion of patients who correctly receive the intervention as per the protocol. The outcome goal will be 90% | 12 weeks |
| Retention Rate | Proportion of participants to complete the study protocol and associated follow up. The outcome goal will be an 80% retention rate | 12 weeks |
| Recruitment rate | Number of patients recruited to the study per month. The outcome goal will be 5 patients per month | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hand volume | Hand volume will be assessed using two validated methods; water displacement and figure of eight measurement. | 12 weeks |
| Patient-reported pain scores | Patient Reported Wrist and Hand Evaluation (PRWHE). The PRWHE allows patients to rate their levels of hand and wrist pain and disability. It is rated on a 0-100 scale. A higher score in the scale denotes a worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lawson Health Research Institute | London | Ontario | Canada |
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| ID | Term |
|---|---|
| D006230 | Hand Injuries |
| D004194 | Disease |
| D000092503 | Wrist Fractures |
| D004387 | Dupuytren Contracture |
| D004487 | Edema |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014954 | Wrist Injuries |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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A Prospective, Randomized Controlled, Double-Blinded Pilot Study
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|
| Surgery | Procedure | This will include regional anaesthesia, tourniquet inflation to 250mmHg and perioperative antibiotics. At the conclusion of the procedure hemostasis will be achieved followed by standard closure technique. There will be three separate surgical groups that will undergo the outlined study protocol: 1) Distal radius fractures will be treated with open reduction from a volar approach only technique 2) Mild dupuytren's: a. Low: i. MCP joints <50 contracture ii. PIP joints <40 contracture b. 1-2 fingers involved 3) Severe dupuytren's a. High: i. MCP joints >50 degree contracture ii. PIP Joints >40 degrees contracture b. >2 fingers involved |
|
| 12 weeks |
| D001134 | Arm Injuries |
| D050723 | Fractures, Bone |
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |