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Background. Consensus is lacking regarding the use of tranexamic acid (TXA) in calcaneal fracture surgery. This study aims to investigate the hypothesis that local infiltration of TXA in the post-operation would maintain hemoglobin (Hb) level, reduce incision drainage volume and risk of infection in patients with displaced intra-articular calcaneal fractures. Methods. A total of 120 patients with displaced intra-articular calcaneal fractures who received extensible lateral L-shaped approach were included in this trial and equally randomized to receive one single dose of 1g TXA or 1g normal saline after closing incision. The demographic data and fracture characteristics, intra-operative indicators, laboratory tests and Visual Analogue Scale (VAS) scores, incision drainage volume, and incision-related complications were collected and compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TXA group | Experimental | Postoperative 1g TXA was infiltrated locally around the incision immediately for patients in TXA group. |
|
| Normal saline group | Placebo Comparator | 1 g 0.9% saline was infiltrated locally around the incision immediately after surgery for patients in normal saline group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | local infiltration of TXA or normal saline in the post-operation would |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incision drain output (mL) | Incision drain output of post-operative day 1 and 2 | 2 days |
| Outcomes of laboratory test | White blood cell (10^9/L) | 4 days |
| Outcomes of laboratory test | Neutrophil count (10^9/L) | 4 days |
| Outcomes of laboratory test | Hemoglobin (g/L) | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of surgical related complications | Complications included oozing of the blood, hematoma, or deep infection etc. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Medical University Third Hospital | Shijiazhuang | Hebei | 050051 | China |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |