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This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are subjectively rated and complications are noted.
This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is rated on a scale of mild, moderate, or severe and given a score of 1-3. Postoperative ecchymosis and edema are subjectively rated by both patient and surgeon on postoperative days 1, 6, and 9 using a similar mild/moderate/severe scale and scored 1-3, respectively. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later |
|
| TXA Group | Experimental | One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 4 hours later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid 100Mg/Ml Inj Vil 10Ml | Drug | IV TXA given during surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative bleeding | Subjective measure of intraoperative blood loss (mild, moderate, or severe) | Surgical time |
| Postoperative ecchymosis | Subjective measure of bruising rated as mild, moderate, or severe | Postoperative day 1 |
| Postoperative ecchymosis | Subjective measure of bruising rated as mild, moderate, or severe | Postoperative day 6 |
| Postoperative ecchymosis | Subjective measure of bruising rated as mild, moderate, or severe | Postoperative day 9 |
| Postoperative edema | Subjective measure of swelling rated as mild, moderate, or severe | Postoperative day 1 |
| Postoperative edema | Subjective measure of swelling rated as mild, moderate, or severe | Postoperative day 6 |
| Postoperative edema | Subjective measure of swelling rated as mild, moderate, or severe | Postoperative day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative hematoma/seroma | Documentation of any postoperative collections seen during the first 10 days following surgery | 10 days postoperative |
| Complications | Documentation of any surgical or postoperative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark J Glasgold, MD | Contact | 732-846-6540 | mglasgold@gmail.com | |
| Justin C Cohen, MD | Contact | 732-846-6540 | justinccohen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mark J Glasgold, MD | Glasgold Group Plastic Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glasgold Group Plastic Surgery | Princeton | New Jersey | 08540 | United States |
Patient demographics, surgical procedure performed, primary and secondary outcomes
Will be made available via publication
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D019066 | Facies |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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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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Randomized, double-blind
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Only the CRNA who is administering the medications is unmasked until completion of the data collection period.
| Normal Saline 0.9% Infusion Solution Bag |
| Drug |
IV saline given during surgery |
|
| 10 days postoperative |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |