Bleeding, Bruising Face, Swelling Lips & Face
Conditions
Keywords
Tranexamic acid, Rhytidectomy, Facelift
Brief summary
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.
Detailed description
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.
Interventions
IV TXA given during surgery
IV saline given during surgery
Sponsors
Glasgold Group Plastic Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Only the CRNA who is administering the medications is unmasked until completion of the data collection period.
Intervention model description
Randomized, double-blind
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Undergoing rhytidectomy surgery at Glasgold Group Plastic Surgery
Exclusion criteria
* History of bleeding disorder, history of thromboembolic events, history of seizure, active use of oral contraceptive pills or hormone replacement therapy, participant preference
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative bleeding | Surgical time | Subjective measure of intraoperative blood loss (mild, moderate, or severe) |
| Postoperative ecchymosis | Postoperative day 1 | Subjective measure of bruising rated as mild, moderate, or severe |
| Postoperative edema | Postoperative day 1 | Subjective measure of swelling rated as mild, moderate, or severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative hematoma/seroma | 10 days postoperative | Documentation of any postoperative collections seen during the first 10 days following surgery |
| Complications | 10 days postoperative | Documentation of any surgical or postoperative complications |
Countries
United States
Contacts
Primary ContactMark J Glasgold, MD
Backup ContactJustin C Cohen, MD
Outcome results
None listed