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| ID | Type | Description | Link |
|---|---|---|---|
| A539730 | Other Identifier | UW Madison | |
| SMPH/SURGERY/DENTL-PLASTC SRGY | Other Identifier | UW Madison | |
| Protocol version 0.11 | Other Identifier | HS-IRB UW, Madison |
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Study closed prior to opening to enrollment, due to funding availability for study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: HA plus TXA | Experimental | HA will be diluted with TXA using a Leur-Lok hub in a ratio of 1.0 mL HA filler to 0.2 mL TXA (100mg/mL) |
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| Control: HA plus Saline | Placebo Comparator | HA will be diluted with saline in a ratio of 1.0 mL HA filler to 0.2 mL saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of Bruising Score | Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising. | Post procedure day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of Bruising Score | Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising. | Post procedure day 1 |
| Intensity of Bruising Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Afifi, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| D006820 | Hyaluronic Acid |
| D006821 | Hyaluronoglucosaminidase |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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half face study where participant serves as own control, intervention on one side of the face, control on the other
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side of face for treatment is randomized and double blinded to the participant and physician
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| Saline | Other | sodium chloride and water for use as control |
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| Hyaluronic acid | Drug | 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 |
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Participant reported intensity of bruising score on a 5 point Likert scale where 1 is no bruising and 5 is severe bruising.
| Post procedure day 30 |
| Intensity of Swelling Score | Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling. | Post procedure day 1 |
| Intensity of Swelling Score | Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling. | Post procedure day 7 |
| Intensity of Swelling Score | Participant reported intensity of swelling score on a 5 point Likert scale where 1 is no swelling and 5 is severe swelling. | Post procedure day 30 |
| Pain Score | Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain. | Post procedure day 1 |
| Pain Score | Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain. | Post procedure day 7 |
| Pain Score | Participants will rate their pain on a scale of 0-10 where 0 is no pain and 10 is the highest pain. | Post procedure day 30 |
| Participant Satisfaction Score | Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied. | Post procedure day 1 |
| Participant Satisfaction Score | Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied. | Post procedure day 7 |
| Participant Satisfaction Score | Participants will rate their satisfaction on a 5 point Likert scale where 1 is completely dissatisfied and 5 is completely satisfied. | Post procedure day 30 |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011133 | Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |