Injection Site Bruising
Conditions
Keywords
patient satisfaction, plastic surgery
Brief summary
The overall purpose of this study is to evaluate the safety and efficacy of co-administration of tranexamic acid (TXA) with hyaluronic acid (HA) in reducing swelling, bruising and pain after facial injection. This will be done by comparing HA to HA+TXA in participants undergoing facial filler injections. Patients undergoing facial filler injections almost always have the same type of injection performed bilaterally in order to maintain symmetry. This provides a unique opportunity where participants can serve as their own controls. Participants will be injected with HA on half of their face and the other half of the face will be injected with HA+TXA. Swelling, bruising, pain, and overall satisfaction will be assessed using participant self-reported surveys, physician surveys, and review of medical records.
Interventions
DRUGTranexamic acid
TXA is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, thus inhibiting degradation of fibrin clots and serving as an antifibrinolytic
OTHERSaline
sodium chloride and water for use as control
DRUGHyaluronic acid
Hyaluronidase is a spreading or diffusing substance which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
side of face for treatment is randomized and double blinded to the participant and physician
Intervention model description
half face study where participant serves as own control, intervention on one side of the face, control on the other
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Age equal to or greater than 18 but less than or equal to 89 years. * Medically appropriate to undergo elective facial filler injection at UW Health by principal investigator * English speaking
Exclusion criteria
* Minors or under the age of 18 * Patient over the age of 89 * Pregnant or breast-feeding women * Individuals unable to give consent due to another condition such as impaired decision-making capacity. * Participants with a history of a thrombotic event (DVT, PE, stroke, MI) or genetic disorder that increases risk of thrombosis * Concurrent use of estrogen * Participant undergoing unilateral facial filler injections * Participants with history of hypersensitivity to TXA or any of the other ingredients * Participants that are on current therapeutic anticoagulation therapy * Participants with stage 2 or greater renal failure * Participants on hemo- or peritoneal dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Bruising Score | Post procedure day 7 | Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Bruising Score | Post procedure day 1 | Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising. |
| Intensity of Swelling Score | Post procedure day 1 | Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling. |
| Pain Score | Post procedure day 1 | Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain. |
| Participant Satisfaction Score | Post procedure day 1 | Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied. |
Countries
United States
Outcome results
None listed